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Insmed (IM8N) Drug Pipeline

Drug pipeline
Drug NameConditionStageStatusStudy NameTrial Start DateArticle
Treprostinil Palmitil Inhalation PowderInterstitial Lung Disease, Progressive Pulmonary FibrosisPhase IIIRecruitingA Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)Sep 01, 2026―
Treprostinil Palmitil Inhalation PowderHepatic ImpairmentPhase IRecruitingA Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Normal Hepatic Function and Participants With Hepatic ImpairmentJun 08, 2026
Treprostinil Palmitil Inhalation PowderPulmonary Arterial HypertensionPhase IIIRecruitingA Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Arterial Hypertension (PAH)Mar 13, 2026
Treprostinil Palmitil Inhalation PowderPulmonary Hypertension, Interstitial Lung DiseasePhase IIIRecruitingAn Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)Nov 14, 2025
Treprostinil Palmitil Inhalation PowderPulmonary Hypertension, Interstitial Lung DiseasePhase IIIRecruitingEfficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)Sep 10, 2025
Tpip F2, Tpip F3Healthy VolunteersPhase IRecruitingA Study to Assess the Relative Bioavailability After a Single Inhalation Administration of Treprostinil Palmitil Inhalation Powder (TPIP) Formulation 2 (F2) to TPIP Formulation 3 (F3) in Healthy ParticipantsJul 28, 2025
BrensocatibHidradenitis SuppurativaPhase IIActive Not RecruitingA Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)Nov 11, 2024
Mometasone Furoate Nasal Spray, BrensocatibChronic Rhinosinusitis Without Nasal PolypsPhase IIActive Not RecruitingA Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)Aug 22, 2023―
Treprostinil PalmitilPulmonary Arterial Hypertensionphase2AndPhase3Active Not RecruitingAn Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)Dec 06, 2022―
Treprostinil Palmitil Inhalation PowderPulmonary Hypertension, Interstitial Lung Diseasephase2AndPhase3CompletedAn Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)Dec 06, 2022

FAQ

What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases: a. Preclinical testing b. Phase 1 – Safety and dosage c. Phase 2 – Effectiveness and side effects d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Insmed (DE:IM8N) have in its pipeline
Insmed DE:IM8N is currently developing the following drugs: Treprostinil Palmitil Inhalation Powder, Tpip F2, Tpip F3, Brensocatib, Mometasone Furoate Nasal Spray, Brensocatib, Treprostinil Palmitil, Azithromycin, Ethambutol, Alis, Brensocatib 10 Mg, Brensocatib 25 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.