Approval Probability
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Also known as Treprostinil Palmitil Inhalation Powder
Treprostinil Palmitil · 10 trials · 6 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.
Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.
| 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. |
| Part A (SAD Cohort 1): TPIP | EXPERIMENTAL | Participants in the single ascending dose (SAD) Cohort 1 received a single dose of TPIP at Dose A, Dose B, or Dose C by oral inhalation on Day 1. |
| Part A (SAD Cohort 2): TPIP or Placebo | EXPERIMENTAL | Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1. |
| Part A (SAD Cohort 3): TPIP or Placebo | EXPERIMENTAL | Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1. |
| Part B (MAD Cohort 1): TPIP or Placebo | EXPERIMENTAL | Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7. |
| Part B (MAD Cohort 2): TPIP or Placebo | EXPERIMENTAL | Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7. |
| 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 being developed for pulmonary arterial hypertension (PAH) and pulmonary hypertension. It is also being studied in healthy volunteers and in people with hepatic impairment to assess safety and pharmacokinetics. The drug is formulated as an inhalation powder and is not yet approved.
Treprostinil Palmitil targets the prostacyclin receptor (PTGIR) and acts as an agonist. By activating this receptor, it is designed to produce effects relevant to treating pulmonary arterial hypertension. The drug is delivered via inhalation powder to potentially improve efficacy and safety compared with other prostacyclin therapies.
Treprostinil Palmitil is being developed by Insmed Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker INSM. Insmed is conducting clinical trials of the drug across multiple countries, including the United States, for pulmonary arterial hypertension and related conditions.
Treprostinil Palmitil is in Phase 1, Phase 2, and Phase 3 clinical trials. A Phase 1 study is recruiting participants with hepatic impairment, while Phase 2 studies have been completed or are active but not recruiting. A Phase 3 trial is currently recruiting patients with pulmonary arterial hypertension.
Treprostinil Palmitil is being studied in four clinical trials. NCT07481981 is a Phase 3 trial in pulmonary arterial hypertension, NCT05649748 is a Phase 2 extension study, NCT05147805 is a completed Phase 2 trial, and NCT07643155 is a Phase 1 trial in hepatic impairment. All are controlled and double-blind.
Yes, Treprostinil Palmitil is also known as Treprostinil Palmitil Inhalation Powder, often abbreviated as TPIP. The drug is administered as an inhalation powder and is being evaluated for pulmonary arterial hypertension. This alternative name is used in clinical trial documentation and publications.