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NCT05147805 (treprostinil palmitil inhalation powder in Pulmonary Arterial Hypertension): BVCT ex-ante prediction vs. reported outcome

On 1 Jan 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 10 Jun 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially probably sufficient.

Clinical Trial

NCTID
NCT05147805
Drug Name
treprostinil palmitil inhalation powder (TPIP)
Drug MoA
synthetic prostacyclin analog
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Respiratory Tract Diseases
Indication
Pulmonary Arterial Hypertension
Human Patients
102
Sponsor
Insmed Incorporated
Phase
Phase 2

Prediction of , index 436

Prospective Prediction
Prediction Index
436
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
526 days in advance
Readout Data Interpretation
TPIP achieved a 35% placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) and 35.5 meters placebo-adjusted improvement in 6MWD (p=0.003) at week 16; slightly superior to sotatercept’s 33 meters placebo-adjusted improvement in 6MWD at week 16 (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2b, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Phase
Phase 2
Status
Completed
Enrollment
102
Lead sponsor
Insmed Incorporated
Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG: Treprostinil Palmitil; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-08-24
Primary completion
2025-03-27
Completion
2025-03-27
Primary outcomes
  • Change from Baseline in Pulmonary Vascular Resistance at Week 16 (Baseline to Week 16)

NCT05147805 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials