> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/deutivacaftor-a97573e7-c2ce-40af-b8ad-ec03a7b92e34
> Record changed: 2026-10-13

# Deutivacaftor

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

First approval year

2024

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

## Development status

**First approval year**

2024

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**Drug name**

Deutivacaftor

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**Molecular weight**

401.55

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**Structure (SMILES)**

These details could not be displayed.

### Brand names (2)

- deutivacaftor component of alyftrek
- Deutivacaftor component of alyftrek

### Other names (22)

- 3 quinolinecarboxamide n 2 1 1 dimethylethyl 4 1 1 di methyl d3 ethyl 2 2 2 d3 5 hydroxyphenyl 1 4 dihydro 4 oxo
- 3-QUINOLINECARBOXAMIDE, N-(2-(1,1-DIMETHYLETHYL)-4-(1,1-DI(METHYL-D3)ETHYL- 2,2,2-D3)-5-HYDROXYPHENYL)-1,4-DIHYDRO-4-OXO-
- ctp 656
- Ctp-656
- CTP-656
- d9 ivacaftor
- D9-ivacaftor
- deuterated ivacaftor
- Deuterated ivacaftor
- deutivacaftor
- Deutivacaftor
- deutivacaftor \[INN\]
- DEUTIVACAFTOR \[USAN\]
- Deutivacaftor \[WHO-DD\]
- deutivacaftor inn
- deutivacaftor usan
- deutivacaftor who dd
- ivacaftor d9
- Ivacaftor d9
- vx 561
- Vx-561
- VX-561

## Identifiers

**CAS registry numbers**

- 1413431-07-8

**ChEMBL ID**

CHEMBL4297603

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**InChIKey**

PURKAOJPTOLRMP-ASMGOKTBSA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297603)

**PubChem compound IDs**

- 71470491

**RxNorm IDs (RxCUI)**

- 2701430

**FDA ingredient codes (UNII)**

- SHA6U5FJZL

## Regulatory information

### United States

**Applicant**

VERTEX PHARMS INC

**Approval date**

20 Dec 2024

**Application number**

NDA218730

### Other regulatory facts

**Patents**

0

**Designations**

1

**First in class**

No

**Fast track**

No

**Breakthrough designation**

No

**Orphan designation**

No

**Priority review**

No

**Orphan exclusivity**

No

**Accelerated approval**

No

**Availability**

Prescription only

## Pharmacology

### Drug classification

**Pharmacology name**

deutivacaftor

**Type**

Synthetic organic

**Drug name stem**

\-caftor; deu-

**Approval recorded by Guide to Pharmacology**

Yes

#### Administration routes

- Oral

### Mechanisms of action (2)

- **Mechanism**  
Cystic fibrosis transmembrane conductance regulator activator

**Action type**  
ACTIVATOR

**Target**  
Cystic fibrosis transmembrane conductance regulator

**Protein identifier**  
P13569
- **Action**  
Potentiation

**Action type**  
POTENTIATION

**Target**  
CFTR

**Gene symbol**  
CFTR

**Protein identifier**  
P13569

**Median affinity**

6.59

**Affinity units**  
pEC50

### Open Targets mechanisms

- **Mechanism**  
Cystic fibrosis transmembrane conductance regulator activator

**Action type**  
ACTIVATOR

**Target**  
Cystic fibrosis transmembrane conductance regulator

### Investigated indications

- **Condition**  
Cystic Fibrosis

**Highest recorded phase**  
3

**Condition identifier**  
MONDO:0009061

**Subject identifier**  
D003550

### Open Targets indications (2)

- **Condition identifier**  
MONDO\_0009061
- **Condition identifier**  
MONDO\_0009061

**Highest recorded phase**  
4

### Reported adverse events (30)

- **Event**  
anaemia

**Reports**  
3

**Reporting signal score**

121.903
- **Event**  
arthralgia

**Reports**  
34

**Reporting signal score**

92.1204
- **Event**  
asthenia

**Reports**  
30

**Reporting signal score**

94.9865
- **Event**  
chest discomfort

**Reports**  
213

**Reporting signal score**

140.753
- **Event**  
cough

**Reports**  
307

**Reporting signal score**

93.5883
- **Event**  
cystic fibrosis

**Reports**  
293

**Reporting signal score**  
1,198.45
- **Event**  
cystic fibrosis lung

**Reports**  
22

**Reporting signal score**

102.279
- **Event**  
cystic fibrosis respiratory infection suppression

**Reports**  
149

**Reporting signal score**

777.268
- **Event**  
distal intestinal obstruction syndrome

**Reports**  
35

**Reporting signal score**

143.455
- **Event**  
fall

**Reports**  
25

**Reporting signal score**

98.9497
- **Event**  
forced expiratory volume decreased

**Reports**  
111

**Reporting signal score**

336.487
- **Event**  
haemoptysis

**Reports**  
166

**Reporting signal score**

243.158
- **Event**  
hospitalisation

**Reports**  
797

**Reporting signal score**  
1,226.93
- **Event**  
hypotension

**Reports**  
5

**Reporting signal score**

114.04
- **Event**  
infection

**Reports**  
388

**Reporting signal score**

353.645
- **Event**  
infective pulmonary exacerbation of cystic fibrosis

**Reports**  
1,801

**Reporting signal score**  
9,298.19
- **Event**  
influenza

**Reports**  
175

**Reporting signal score**

107.378
- **Event**  
liver function test increased

**Reports**  
120

**Reporting signal score**

146.861
- **Event**  
lung infection

**Reports**  
108

**Reporting signal score**

157.256
- **Event**  
lung transplant

**Reports**  
57

**Reporting signal score**

124.254
- **Event**  
neutropenia

**Reports**  
4

**Reporting signal score**

85.1164
- **Event**  
pain

**Reports**  
33

**Reporting signal score**

132.748
- **Event**  
pain in extremity

**Reports**  
13

**Reporting signal score**

88.6917
- **Event**  
pruritus

**Reports**  
18

**Reporting signal score**

85.981
- **Event**  
pseudomonas infection

**Reports**  
76

**Reporting signal score**

149.189

And 5 more, listed on the interactive page.

### Trial references (11)

- NCT02971839  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02971839)
- NCT03224351  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03224351)
- NCT03227471  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03227471)
- NCT03911713  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03911713)
- NCT03912233  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03912233)
- NCT05033080  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05033080)
- NCT05076149  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05076149)
- NCT05422222  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05422222)
- NCT05437120  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05437120)
- NCT05444257  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05444257)
- NCT05535959  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05535959)

## Dosing

**Dose**

2 tablets of vanzacaftor 10 mg/tezacaftor 50 mg/deutivacaftor 125 mg

**Route**

Oral

**How often**

Once daily

## Chemical properties

**Hydrogen bond acceptors**

3

**Hydrogen bond donors**

3

**Polar surface area**

82.19

**Calculated partition coefficient (ALogP)**

5.08

**Calculated partition coefficient (XLogP)**

5.6

**Prodrug**

No

**Chirality**

Achiral

**Inorganic**

No

**Rule-of-five violations**

1

**Rotatable bonds**

2

**Heavy atoms**

29

**Molecular formula**

C24H28N2O3

**Monoisotopic mass**

401.26648347

**Natural product**

No

## National Drug Codes

- 51167-121
- 51167-135

## Related records

### Trials (8)

- A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
- A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
- A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
- A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
- [Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis](https://trialight.com/data/trial/evaluation-of-vx-828-in-healthy-participants-and-in-7648273e-ae83-4332-a1e0-005b2100ed65.md)
- Food Effect Study of CTP-656 in Healthy Male Volunteers
- Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
- Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations

### In development for (1)

- [Cystic fibrosis](https://trialight.com/data/condition/cystic-fibrosis-6f9870eb-6ebc-5bec-a50b-34b0b323a7c3.md) Phase 3

### Targets (1)

- [CFTR](https://trialight.com/data/target/cftr-1582a227-49f3-5e47-a81a-1acc4b67f420.md) Cystic fibrosis transmembrane conductance regulator activator

---

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