MedPath

Insmed

🇺🇸United States
Ownership
-
Employees
912
Market Cap
$13.2B
Website
Introduction

Insmed, Inc. is a global biopharmaceutical company, which engages in the development and commercialization of therapies for patients with rare diseases. Its focuses on Brensocatib, and Treprostinil Palmitil Inhalation Powder (TPIP) pipeline. The company was founded in 1988 and is headquartered in Bridgewater, NJ.

Clinical Trials

146

Active:97
Completed:36

Trial Phases

4 Phases

Phase 1:89
Phase 2:17
Phase 3:11
+1 more phases

Drug Approvals

1

FDA:1

Drug Approvals

ARIKAYCE

Approval Date
Feb 8, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (121 trials with phase data)• Click on a phase to view related trials

Phase 1
89 (73.6%)
Phase 2
17 (14.0%)
Phase 3
11 (9.1%)
Not Applicable
3 (2.5%)
phase_2_3
1 (0.8%)

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

Not Applicable
Not yet recruiting
Conditions
Healthy Volunteers
Interventions
Drug: TPIP F2
Drug: TPIP F3
First Posted Date
2025-08-03
Last Posted Date
2025-08-03
Lead Sponsor
Insmed Incorporated
Target Recruit Count
42
Registration Number
NCT07102316

An Expanded Access Study to Assess Treprostinil Palmitil Inhalation Powder (TPIP) for Participants With Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)

Conditions
Pulmonary Arterial Hypertension
Pulmonary Hypertension, Interstitial Lung Disease
First Posted Date
2025-04-23
Last Posted Date
2025-06-27
Lead Sponsor
Insmed Incorporated
Registration Number
NCT06939647

A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)

Phase 2
Recruiting
Conditions
Hidradenitis Suppurativa
Interventions
Drug: Placebo
First Posted Date
2024-11-13
Last Posted Date
2025-08-20
Lead Sponsor
Insmed Incorporated
Target Recruit Count
204
Registration Number
NCT06685835
Locations
🇺🇸

USA001, Phoenix, Arizona, United States

🇺🇸

USA007, Sacramento, California, United States

🇺🇸

USA026, Coral Gables, Florida, United States

and more 65 locations

A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants

Phase 1
Completed
Conditions
Healthy Participants
Interventions
First Posted Date
2024-04-03
Last Posted Date
2024-06-13
Lead Sponsor
Insmed Incorporated
Target Recruit Count
24
Registration Number
NCT06344728
Locations
🇺🇸

USA001, Dallas, Texas, United States

Single Dose Escalation Study of TR02 (Sustained Lipid Inhalation Technology [SLIT™] Amikacin) in Participants With Cystic Fibrosis (CF) Having Chronic Infections of Pseudomonas Aeruginosa

Phase 1
Completed
Conditions
Cystic Fibrosis
Interventions
First Posted Date
2024-02-02
Last Posted Date
2024-02-02
Lead Sponsor
Insmed Incorporated
Target Recruit Count
18
Registration Number
NCT06238856
  • Prev
  • 1
  • 2
  • 3
  • 4
  • 5
  • 9
  • Next

News

Insmed Reports Strong Q2 2025 Results with ARIKAYCE Growth and Brensocatib Approval Pending

Insmed achieved $107.4 million in ARIKAYCE revenue for Q2 2025, representing 19% growth compared to the same quarter in 2024, with growth across all geographic regions.

Insmed Opens Cambridge R&D Facility Focused on Synthetic Rescue Platform for Rare Diseases

Princess Anne officially opened Insmed's new 17,000 square foot research facility in Cambridge, UK, dedicated to synthetic rescue technology for rare diseases.

Insmed's TPIP Achieves Breakthrough Results in Phase 2b PAH Trial with 35% Reduction in Pulmonary Vascular Resistance

Insmed's treprostinil palmitil inhalation powder (TPIP) met its primary endpoint with a statistically significant 35% placebo-adjusted reduction in pulmonary vascular resistance in patients with pulmonary arterial hypertension.

Non-Cystic Fibrosis Bronchiectasis Market Expected to Reach USD 7.5 Billion by 2035, Driven by Novel Therapies

The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow from USD 1.7 billion in 2024 to USD 7.5 billion by 2035, representing a robust CAGR of 14.62%.

EMA Evaluates Fast-Track Status for Three Novel Therapeutics from Scholar, Insmed, and Soleno

• The European Medicines Agency is reviewing accelerated assessment requests for three innovative drugs - apitegromab, brensocatib, and diazoxide choline - based on their potential major public health impact. • Scholar Rock's apitegromab, Insmed's brensocatib, and Soleno's diazoxide choline are being evaluated for their therapeutic innovation potential in addressing significant unmet medical needs. • The fast-track designation, if granted, would expedite the regulatory review process for these promising therapeutics, potentially bringing them to patients more quickly.

AN2 Therapeutics Shifts Phase 3 MAC Lung Disease Trial to Quality of Life Endpoint

AN2 Therapeutics has selected Quality of Life-Bronchiectasis (QOL-B) respiratory domain as the new primary efficacy endpoint for their Phase 3 EBO-301 trial in treatment-refractory MAC lung disease.

FDA Grants Priority Review to Brensocatib for Non-Cystic Fibrosis Bronchiectasis Treatment

The FDA has accepted Insmed's New Drug Application for brensocatib, setting a PDUFA target action date of August 12 under Priority Review designation.

Insmed's Gene Therapy Receives IND Clearance, Aiming to Transform DMD Treatment

Insmed's novel gene therapy candidate for Duchenne Muscular Dystrophy (DMD) has received IND clearance, paving the way for clinical trials.

Insmed's Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025

The FDA has accepted Insmed's New Drug Application for brensocatib in bronchiectasis, granting Priority Review with a PDUFA target action date of August 12, 2025.

NCFB Pipeline Shows Promise with Over 15 Companies Developing New Therapies

• The non-cystic fibrosis bronchiectasis (NCFB) market is experiencing growth due to rising prevalence and increased awareness, leading to early diagnosis and treatment. • Over 15 companies are actively developing more than 15 NCFB drugs, aiming to improve the treatment landscape for this chronic lung condition. • Key players like Insmed, AstraZeneca, and Verona Pharma are advancing promising therapies such as brensocatib, benralizumab and ensifentrine through clinical trials. • Recent clinical trial milestones, including Phase III results for brensocatib and Phase II enrollment for AP-PA02, signal progress in addressing unmet needs in NCFB treatment.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.