Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Treprostinil Palmitil Inhalation Powder, INS1009
Treprostinil Palmitil · 9 trials · 5 indications
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
Determination of the effect of mild, moderate, and severe hepatic impairment on the PK of TP and TRE following a single dose of TPIP, when compared to normal hepatic function.
| Arm | Type | Description |
|---|---|---|
| Treprostinil Palmitil Inhalation Powder (TPIP) | EXPERIMENTAL | Participants will receive TPIP, once daily (QD), at a starting dose of 80 micrograms (μg) to the maximum tolerated dose (up to 1280 μg) for up to 104 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a TPIP-matching placebo, QD for up to 104 weeks. |
| 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. |
| Treprostinil Palmitil | EXPERIMENTAL | Participants will be administered TPIP once per day at a starting dose of 80 micrograms (μg). Participants will be titrated up to the highest tolerated dose for each individual participant of between 80 μg and 640 μg during the initial 3 weeks of treatment. The overall treatment period will be 16 weeks. |
| Group 1: Treprostinil Palmitil Inhalation Powder | EXPERIMENTAL | Healthy participants with normal hepatic function will receive a single dose of TPIP on Day 1. |
| Group 2: Treprostinil Palmitil Inhalation Powder | EXPERIMENTAL | Participants with mild hepatic impairment (classified based on the numerical Child-Pugh total score of 5 to 6) will receive a single dose of TPIP on Day 1. |
| Group 3: Treprostinil Palmitil Inhalation Powder | EXPERIMENTAL | Participants with moderate hepatic impairment (classified based on the numerical Child-Pugh total score of 7 to 9) will receive a single dose of TPIP on Day 1. |
| Group 4: Treprostinil Palmitil Inhalation Powder | EXPERIMENTAL | Participants with severe hepatic impairment (classified based on the numerical Child-Pugh total score of 10 to 15) will receive a single dose of TPIP on Day 1. |
| 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: * Radiologic evidence of pulmonary fibrosis of \>10% extent on high-resolution computed tomography (HRCT) in the previous 12 months. * Diagnosis of interstitial lung disease (ILD) (other than idiopathic pulmonary fibrosis \[IPF\]) that fulfills at least 1 of the following criter...
Treprostinil Palmitil is an investigational small molecule developed by Insmed Incorporated (ticker INSM) as an inhalation powder. It is being studied in hepatic impairment, progressive pulmonary fibrosis, pulmonary arterial hypertension, and pulmonary hypertension associated with interstitial lung disease. It is not approved and remains in clinical development.
Treprostinil Palmitil targets PTGIR, the prostacyclin IP receptor, and acts as an agonist. By activating this receptor, the drug is designed to mimic prostacyclin signaling in the pulmonary vasculature. This mechanism underlies its study in pulmonary hypertension and pulmonary fibrosis indications.
Insmed Incorporated, which trades under the ticker INSM, is developing Treprostinil Palmitil. The company is running the clinical program for the inhalation powder across pulmonary and hepatic impairment indications.
Treprostinil Palmitil is investigational and in clinical development. Four trials are registered, with two active and two completed. The program includes Phase 3 studies in progressive pulmonary fibrosis, pulmonary arterial hypertension, and pulmonary hypertension associated with interstitial lung disease, plus a Phase 1 hepatic impairment study.
Registered trials include NCT07805785, a Phase 3 study in progressive pulmonary fibrosis, NCT07481981, a Phase 3 study in pulmonary arterial hypertension, NCT07234032, an open-label extension in pulmonary hypertension with interstitial lung disease, and NCT07643155, a Phase 1 pharmacokinetics and safety study in hepatic impairment.
Yes. Treprostinil Palmitil Inhalation Powder, often abbreviated TPIP, is the same investigational asset as Treprostinil Palmitil. The full name describes the inhaled powder formulation developed by Insmed Incorporated (ticker INSM) for pulmonary and hepatic impairment indications.