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Insmed (INSM)
NASDAQ:INSM
Treprostinil Palmitil Inhalation Powder
Pulmonary Hypertension, Interstitial Lung Disease
Phase III
Not Yet Recruiting
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Sep 10, 2025
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Tpip F2, Tpip F3
Healthy Volunteers
Phase I
Recruiting
A 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 Participants
Jul 28, 2025
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Brensocatib
Hidradenitis Suppurativa
Phase II
Recruiting
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
Nov 11, 2024
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Mometasone Furoate Nasal Spray (Mfns), Brensocatib
Chronic Rhinosinusitis Without Nasal Polyps
Phase II
Active Not Recruiting
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
Aug 22, 2023
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Treprostinil Palmitil
Pulmonary Arterial Hypertension
Phase II/III
Active Not Recruiting
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH)
Dec 06, 2022
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Treprostinil Palmitil Inhalation Powder
Pulmonary Hypertension, Interstitial Lung Disease
Phase II/III
Active Not Recruiting
An Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Dec 06, 2022
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Treprostinil Palmitil
Pulmonary Hypertension
Phase II
Completed
A Study to Evaluate the Safety and Tolerability of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease
Dec 10, 2021
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Treprostinil Palmitil
Pulmonary Arterial Hypertension
Phase II
Completed
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension
Nov 24, 2021
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Azithromycin, Ethambutol, Alis
Mycobacterium Infections, Nontuberculous
Phase III
Active Not Recruiting
Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex
Dec 16, 2020
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Brensocatib 10 Mg, Brensocatib 25 Mg
Non-Cystic Fibrosis Bronchiectasis
Phase III
Completed
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
Oct 14, 2020
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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
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 (INSM) have in its pipeline
INSM is currently developing the following drugs: Treprostinil Palmitil Inhalation Powder, Tpip F2, Tpip F3, Brensocatib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.