ELEXACAFTOR

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C26H34F3N7O4S
Molecular Weight	597.653
Optical Activity	UNSPECIFIED
Defined Stereocenters	1 / 1
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

C[C@@H]1CN(C2=NC(=CC=C2C(=O)NS(=O)(=O)C3=CN(C)N=C3C)N4C=CC(OCC(C)(C)C(F)(F)F)=N4)C(C)(C)C1

InChI

InChIKey=MVRHVFSOIWFBTE-INIZCTEOSA-N

InChI=1S/C26H34F3N7O4S/c1-16-12-25(5,6)35(13-16)22-18(23(37)33-41(38,39)19-14-34(7)31-17(19)2)8-9-20(30-22)36-11-10-21(32-36)40-15-24(3,4)26(27,28)29/h8-11,14,16H,12-13,15H2,1-7H3,(H,33,37)/t16-/m0/s1

HIDE SMILES / InChI

Molecular Formula	C26H34F3N7O4S
Molecular Weight	597.653
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	1 / 1
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf|https://pubmed.ncbi.nlm.nih.gov/31784874

Elexacaftor (VX-445) is a next-generation cystic fibrosis transmembrane conductance regulator (CFTR) corrector. It received FDA approval in October 2019 in combination with tezacaftor and ivacaftor as the combination product Trikafta for the treatment of cystic fibrosis in patients aged ≥ 12 years who have ≥ 1 F508del mutation in the CFTR gene. Trikafta™ has been developed by Vertex Pharmaceuticals Inc. to treat patients with the most common cystic fibrosis mutation (F508del). Its use has been associated with statistically significant and/or clinically meaningful improvements in lung function and respiratory-related quality of life compared with comparator regimens (placebo or ivacaftor/tezacaftor) in multinational phase II and III studies. Elexacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of select mutant forms of CFTR (including F508del-CFTR) to increase the amount of CFTR protein delivered to the cell surface compared to either molecule alone. Ivacaftor potentiates the channel open probability (or gating) of the CFTR protein at the cell surface.

CNS Activity

Approval Year

Targets

Primary Target	Pharmacology	Condition	Potency
Cystic fibrosis transmembrane conductance regulator 7 Target ID: CHEMBL4051 Sources: https://pubmed.ncbi.nlm.nih.gov/34615919\|https://pubmed.ncbi.nlm.nih.gov/30334692\|https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf	Modulator 846		1.5 nM [EC50]

Conditions

Condition	Modality	Targets	Highest Phase	Product
Cystic fibrosis 120 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212273s004lbl.pdf	Primary		Approved 8583	TRIKAFTA Approved Use TRIKAFTA is a combination of ivacaftor, a CFTR potentiator, tezacaftor, and elexacaftor indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the CFTR gene or a mutation in the CFTR gene that is responsive based on in vitro data. Launch Date 2019

C_max

Value	Dose	Co-administered	Analyte	Population
1.07 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
2.46 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: LOW-FAT
4.01 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
3.03 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=186	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
0.407 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
1.03 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	60 mg single, oral dose: 60 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
2.54 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	120 mg single, oral dose: 120 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
4.7 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	240 mg single, oral dose: 240 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
7.17 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	360 mg single, oral dose: 360 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
0.761 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=193	20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
1.2 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	60 mg 1 times / day multiple, oral dose: 60 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
2.15 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	60 mg 1 times / day multiple, oral dose: 60 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
2.89 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	120 mg 1 times / day multiple, oral dose: 120 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
6.03 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	120 mg 1 times / day multiple, oral dose: 120 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
3.81 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	240 mg 1 times / day multiple, oral dose: 240 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
11.8 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	240 mg 1 times / day multiple, oral dose: 240 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
11.6 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	340 mg 1 times / day multiple, oral dose: 340 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
18.8 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	340 mg 1 times / day multiple, oral dose: 340 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
9.99 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=200	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
20.9 μg/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=200	400 mg 1 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
8400 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=69	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: UNHEALTHY age: CHILD sex: FEMALE / MALE food status: UNKNOWN
8770 ng/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=69	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: UNHEALTHY age: CHILD sex: FEMALE / MALE food status: UNKNOWN

AUC

Value	Dose	Co-administered	Analyte	Population
99 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
117 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: LOW-FAT
152 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
107 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=186	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
12.8 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
32.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	60 mg single, oral dose: 60 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
94.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	120 mg single, oral dose: 120 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
131 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	240 mg single, oral dose: 240 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
290 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	360 mg single, oral dose: 360 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
14.5 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=193	20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
18.2 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	60 mg 1 times / day multiple, oral dose: 60 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
36.9 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	60 mg 1 times / day multiple, oral dose: 60 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
42.8 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	120 mg 1 times / day multiple, oral dose: 120 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
103 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	120 mg 1 times / day multiple, oral dose: 120 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
61.6 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	240 mg 1 times / day multiple, oral dose: 240 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
214 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	240 mg 1 times / day multiple, oral dose: 240 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
123 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	340 mg 1 times / day multiple, oral dose: 340 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
355 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	340 mg 1 times / day multiple, oral dose: 340 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
186 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=200	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
395 μg × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=200	400 mg 1 times / day multiple, oral dose: 400 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
149000 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=69	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: UNHEALTHY age: CHILD sex: FEMALE / MALE food status: UNKNOWN
167000 ng × h/mL OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=69	200 mg 1 times / day multiple, oral dose: 200 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: UNHEALTHY age: CHILD sex: FEMALE / MALE food status: UNKNOWN

T_1/2

Value	Dose	Co-administered	Analyte	Population
24.7 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=54	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered:		ELEXACAFTOR plasma	Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN
32.8 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FASTED
23.1 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: LOW-FAT
22.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=60 \| https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=210	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
20.31 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=186	200 mg single, oral dose: 200 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN
20.7 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
18.6 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	60 mg single, oral dose: 60 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
23.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	120 mg single, oral dose: 120 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
16.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	240 mg single, oral dose: 240 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
21.5 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=192	360 mg single, oral dose: 360 mg route of administration: Oral experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
20.8 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=193	20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN
17.6 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	60 mg 1 times / day multiple, oral dose: 60 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
20.4 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	120 mg 1 times / day multiple, oral dose: 120 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
27.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	240 mg 1 times / day multiple, oral dose: 240 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED
23.9 h OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=196	340 mg 1 times / day multiple, oral dose: 340 mg route of administration: Oral experiment type: MULTIPLE co-administered: TEZACAFTOR	TEZACAFTOR	ELEXACAFTOR plasma	Homo sapiens population: HEALTHY age: ADULT sex: UNKNOWN food status: FED

F_unbound

Value	Dose	Co-administered	Analyte	Population
0.007% OTHER GOV'T https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf#page=40			ELEXACAFTOR plasma	Homo sapiens

Doses

Dose	Population	Adverse events
200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	Disc. AE: Rash, Alanine aminotransferase increased... AEs leading to discontinuation/dose reduction: Rash (2%) Alanine aminotransferase increased (1%) exacerbation of cystic fibrosis (1%) Influenza (1%) Rhabdomyolysis (1%) Intestinal obstruction (1%) Rash (1 patient) portal hypertension (1 patient) Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
340 mg 1 times / day steady, oral Highest studied dose Dose: 340 mg, 1 times / day Route: oral Route: steady Dose: 340 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	healthy Health Status: healthy Sex: unknown Food Status: FED Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
360 mg single, oral Highest studied dose Dose: 360 mg Route: oral Route: single Dose: 360 mg Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	healthy Health Status: healthy Sex: M Food Status: FED Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf

AEs

AE	Significance	Dose	Population
Rash	1 patient Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
portal hypertension	1 patient Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
Alanine aminotransferase increased	1% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
Influenza	1% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
Intestinal obstruction	1% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
Rhabdomyolysis	1% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
exacerbation of cystic fibrosis	1% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf
Rash	2% Disc. AE	200 mg 1 times / day steady, oral Recommended\|Studied dose Dose: 200 mg, 1 times / day Route: oral Route: steady Dose: 200 mg, 1 times / day Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf	unhealthy, ADULT Health Status: unhealthy Age Group: ADULT Sex: M+F Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inducer 1087 substrate 1946 inhibitor 2252	inhibitor 2438 inducer 440	inhibitor 2507 inducer 109	inhibitor 2217

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
P-gp 1741 CYP2C8 1057 OATP1B1 1079 OATP1B3 961 CYP1A2 2153 CYP2B6 926 CYP2C19 2057	CYP3A5 446 P-gp 2052 OATP1B1 503 OATP1B3 435	CYP2C8 198 P-gp 301 CYP1A2 832 CYP2B6 669 CYP2C19 329

Drug as perpetrator

Target	Modality	Activity	Metabolite
CYP1A2 2333	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	likely	VRT-1654548 1
CYP2B6 1160	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	likely	VRT-1654548 1
CYP3A4 2633	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	likely	VRT-1654548 1
CYP1A2 2333	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42 \| 72	no
CYP1A2 2333	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2B6 1160	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42 \| 72	no
CYP2B6 1160	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2C19 2141	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2C19 2141	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2C8 1117	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2C9 2497	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2D6 2546	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2D6 2546	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP3A4 2633	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42 \| 72	no
CYP3A4 2633	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 72.0	no
CYP2C9 2497	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	weak [IC50 10.9 uM]
CYP2C8 1117	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	weak [IC50 16.7 uM]
CYP2C9 2497	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak [IC50 20.7 uM]	VRT-1654548 1
CYP2C8 1117	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak [IC50 20.8 uM]	VRT-1654548 1
P-gp 1932	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	weak [IC50 23.8 uM]
CYP2C19 2141	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak [IC50 25.5 uM]	VRT-1654548 1
P-gp 1932	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak [IC50 25.6 uM]	VRT-1654548 1
OATP1B1 1095	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	weak
OATP1B1 1095	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak	VRT-1654548 1
OATP1B3 970	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	weak
OATP1B3 970	inhibitor 4027 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	weak	VRT-1654548 1
P-gp 1932	inducer 1966 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	yes	VRT-1654548 1

Drug as victim

Target	Modality	Activity	Metabolite	Clinical evidence
CYP3A5 446	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 40 \| 61	major
CYP3A4 1946	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 40 \| 61 \| 70	major		yes (co-administration study) Comment: Itraconazole increased AUCinf and Cmax by 2.83-fold and 1.05-fold Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 40 \| 61 \| 70
OATP1B1 503	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 42	no
OATP1B1 503	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	no	VRT-1654548 1
OATP1B3 435	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41.0	no
OATP1B3 435	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 42.0	no	VRT-1654548 1
P-gp 2052	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 41 \| 60	yes
P-gp 2052	substrate 4014 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 60.0	yes	VRT-1654548 1

Tox targets

Target	Modality	Activity	Metabolite	Clinical evidence
hERG 2263	inhibitor 2237 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212273Orig1s000MultidisciplineR.pdf Page: 37.0

PubMed

Title	Date	PubMed
The Impact of Elexacaftor/Ivacaftor/Tezacaftor on Cystic Fibrosis Patients Who Acquire COVID-19 Infection.	2022-09	36277555
Mental status changes during elexacaftor/tezacaftor / ivacaftor therapy.	2022-03	34742667
Elexacaftor-Tezacaftor-Ivacaftor: The First Triple-Combination Cystic Fibrosis Transmembrane Conductance Regulator Modulating Therapy.	2020	32265602
Elexacaftor/Ivacaftor/Tezacaftor: First Approval.	2019-12	31784874

Patents

Sample Use Guides

In Vivo Use Guide

12 years and older: Two tablets, each containing elexacaftor 100 mg/tezacaftor 50 mg/ivacaftor 75 mg

Route of Administration: Oral

In Vitro Use Guide

The acute potentiating efect of VX-445 appeared saturating at~100 nM (It,max=3.22±0.384 uA cm−2) with an EC50 of 1.50±1.40 nM.

Substance Class	Chemical Created by `admin` on `Tue Apr 01 20:36:10 GMT 2025` Edited by `admin` on `Tue Apr 01 20:36:10 GMT 2025`
Record UNII	RRN67GMB0V
Record Status	`Validated (UNII)`
Record Version

Download

Name

Type

Language

ELEXACAFTOR

Official Name

English

TRIKAFTA COMPONENT ELEXACAFTOR

Preferred Name

English

Elexacaftor [WHO-DD]

Common Name

English

ELEXACAFTOR [USAN]

Common Name

English

ELEXACAFTOR [MI]

Common Name

English

VX-445

Code

English

N-(1,3-Dimethyl-1H-pyrazole-4-sulfonyl)-6-[3-(3,3,3-trifluoro-2,2-dimethylpropoxy)-1H-pyrazol-1-yl]-2-[(4S)-2,2,4-trimethylpyrrolidin-1-yl]pyridine-3-carboxamide

Systematic Name

English

elexacaftor [INN]

Common Name

English

3-PYRIDINECARBOXAMIDE, N-((1,3-DIMETHYL-1H-PYRAZOL-4-YL)SULFONYL)-6-(3-(3,3,3-TRIFLUORO-2,2-DIMETHYLPROPOXY)-1H-PYRAZOL-1-YL)-2-((4S)-2,2,4-TRIMETHYL-1-PYRROLIDINYL)-

Code

English

ELEXACAFTOR [ORANGE BOOK]

Common Name

English

Classification Tree Code System Code

EU-Orphan Drug

EU/3/18/2116