Brinsupri

(Brensocatib)

Small molecule

IInsmed Incorporated

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Cystic Fibrosis4 trials

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

Completed·IInsmed Incorporated·Phase 2·NCT05090904·29 enrolled

An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis

Approved for marketing·IInsmed Incorporated··NCT05344508

A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis

Completed·IInsmed Incorporated·Phase 3·NCT04594369·1,767 enrolled

Show 1 more trial

Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis

Completed·IInsmed Incorporated·Phase 2·NCT03218917·256 enrolled

Tics2 trials

A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT05826574·32 enrolled

A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT05965570·22 enrolled

COVID-191 trial

STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19

Completed·UUniversity of Dundee·Phase 3·NCT04817332·406 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Completed·IInsmed Incorporated·Phase 1·NCT05517525·30 enrolled

Chronic Rhinosinusitis Without Nasal Polyps1 trial

A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Completed·IInsmed Incorporated·Phase 2·NCT06013241·288 enrolled

5 more indications

Acceptability1 trial

A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT06178783·20 enrolled

ART1 trial

A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants

Completed·IInsmed Incorporated·Phase 1·NCT05355935·48 enrolled

Renal Impairment1 trial

A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment

Completed·IInsmed Incorporated·Phase 1·NCT05673603·28 enrolled

Pediatric1 trial

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

Completed·IInsmed Incorporated·Phase 1·NCT06344728·24 enrolled

Hidradenitis Suppurativa1 trial

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa - The CEDAR Study

Terminated·IInsmed Incorporated·Phase 2·NCT06685835·214 enrolled

Regulatory

FDA Approval Timeline[3]

Aug 12, 2025

BRINSUPRI

NDA NDA217673

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Brensocatib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brensocatib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA217673). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Brinsupri. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Insmed Incorporated company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: IInsmed Incorporated

Patent Landscape[4]

Patent Cliff

Jan 21, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12054465Jan 21, 2035

11814359Jan 21, 2035

11773069Jan 21, 2035

11673871Jan 21, 2035

11655224Jan 21, 2035

9 more patents

11655223Jan 21, 2035

11655222Jan 21, 2035

11655221Jan 21, 2035

10669245Jan 21, 2035

10287258Jan 21, 2035

9815805Jan 21, 2035

9522894Mar 12, 2035

12201638Mar 1, 2039

12059424Feb 21, 2040