Success Metrics

Clinical Success Rate
95.2%

Based on 40 completed trials

Completion Rate
95%(40/42)
Active Trials
2(4%)
Results Posted
83%(33 trials)
Terminated
2(4%)

Phase Distribution

Ph phase_4
1
2%
Ph phase_2
13
28%
Ph phase_1
5
11%
Ph early_phase_1
2
4%
Ph not_applicable
2
4%
Ph phase_3
21
46%

Phase Distribution

7

Early Stage

13

Mid Stage

22

Late Stage

Phase Distribution44 total trials
Early Phase 1First-in-human
2(4.5%)
Phase 1Safety & dosage
5(11.4%)
Phase 2Efficacy & side effects
13(29.5%)
Phase 3Large-scale testing
21(47.7%)
Phase 4Post-market surveillance
1(2.3%)
N/ANon-phased studies
2(4.5%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

93.0%

40 of 43 finished

Non-Completion Rate

7.0%

3 ended early

Currently Active

2

trials recruiting

Total Trials

46

all time

Status Distribution
Active(2)
Completed(40)
Terminated(3)
Other(1)

Detailed Status

Completed40
Terminated2
Recruiting2
unknown1
Withdrawn1

Development Timeline

Analytics

Development Status

Total Trials
46
Active
2
Success Rate
95.2%
Most Advanced
Phase 4

Trials by Phase

Early Phase 12 (4.5%)
Phase 15 (11.4%)
Phase 213 (29.5%)
Phase 321 (47.7%)
Phase 41 (2.3%)
N/A2 (4.5%)

Trials by Status

unknown12%
terminated24%
recruiting24%
completed4087%
withdrawn12%

Recent Activity

Clinical Trials (46)

Showing 20 of 46 trialsScroll for more
NCT03439865Early Phase 1

Ivacaftor for Acquired CFTR Dysfunction in Chronic Rhinosinusitis

Recruiting
NCT06237335Phase 2

A Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF

Recruiting
NCT02070744Phase 2

Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion

Completed
NCT04126473Phase 2

A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele

Completed
NCT04135495Phase 2

A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele

Completed
NCT03783286

Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects

Completed
NCT04066751Phase 2

The Multicenter Topic Trial

Withdrawn
NCT02871778Phase 2

Clearing Lungs With ENaC Inhibition in Primary Ciliary Dyskinesia

Completed
NCT02508207Phase 2

A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Completed
NCT02445053

Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)

Completed
NCT01784419Not Applicable

Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients

Completed
NCT03068312Phase 3

A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation

Completed
NCT02730208Phase 2

A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Completed
NCT03150719Phase 3

A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)

Completed
NCT02310789Not Applicable

(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?

Completed
NCT02412111Phase 3

A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor

Completed
NCT02742519Phase 3

A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation

Terminated
NCT02934698Phase 3

An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations

Completed
NCT02516410Phase 3

A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation

Completed
NCT02347657Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor

Completed

Drug Details

Intervention Type
DRUG
Total Trials
46