Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07481981 | A Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH) | PHASE3 | RECRUITING | 344 | — | — | Jun 26, 2026 | Jan 28, 2029 | May 26, 2026 | 1 | United States |
| NCT05649748 | An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH) | PHASE2 | ACTIVE NOT_RECRUITING | 91 | — | — | Mar 7, 2023 | Dec 31, 2026 | May 28, 2026 | 45 | United States, Argentina +13 |
| NCT05147805 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension | PHASE2 | COMPLETED | 102 | — | — | Aug 24, 2022 | Mar 27, 2025 | Mar 30, 2026 | 92 | United States, Argentina +15 |
| Arm | Type | Description |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | EXPERIMENTAL | Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) up to maximum tolerated dose (up to 1280 μg) for 24 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a TPIP-matching placebo, QD, for 24 weeks. |
| Treprostinil Palmitil Inhalation Powder (TPIP) | EXPERIMENTAL | Participants who are not transitioning immediately from other TPIP studies:INS1009-201(NCT04791514), INS1009-202(NCT05147805) and other lead-in studies, will be given TPIP, once daily (QD), starting with 80 micrograms (μg), up-titrated to highest tolerated dose between 80 μg and 640 μg during 3-week titration period that maybe increased upto maximum dose of 1280 μg QD post initial titration, per investigator's assessment. Overall treatment period=24 months. Participants transitioning immediately from randomized blinded lead-in TPIP study and who previously received: 1. TPIP- will be given placebo QD(80 μg upto achieved TPIP dose from previous study)along with achieved TPIP dose from previous study in blinded manner during 3-week titration period. 2. Placebo- will be given TPIP QD (80 μg up to achieved placebo dose from previous study)along with achieved placebo dose from previous study in blinded manner during 3-week titration period.Overall treatment period=24 months. |
| Name | Type | Description |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder | DRUG | Oral inhalation using a capsule-based dry powder inhaler device. |
| Placebo | DRUG | Oral inhalation using a capsule-based dry powder inhaler device. |
| Treprostinil Palmitil | DRUG | Administered by oral inhalation, using a Plastiape capsule-based dry powder inhaler. |
Inclusion Criteria * Participants must have a diagnosis of World Health Organisation (WHO) Group 1 pulmonary hypertension (PAH) in any of the following subtypes, in accordance with European Society of Cardiology European Respiratory Society (ESC/ERS) Guidelines: * Idiopathic PAH * Heritable PA...