PharmaRadar360

PharmaRadar360

RespiratoryDrug intelligence

Brinsupri

Brensocatib

Dipeptidyl peptidase 1 (DPP1) inhibitor. Developed by Insmed. Clinical, regulatory, and source evidence are connected below.

Company
Insmed
Target / MOA
DPP1 路 CTSC
Aliases
Brinsupri
Signals
21
Clinical trials
16
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Phase 1 路 NOT_YET_RECRUITING 路 Insmed Incorporated

clinical trialClinicalTrials.gov

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

Phase 2 路 COMPLETED 路 Insmed Incorporated

clinical trialClinicalTrials.gov

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

Phase 2 路 TERMINATED 路 Insmed Incorporated

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Brinsupri 路 NDA217673 路 label version 3, effective Mar 16, 2026 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older.

European Union (EMA)

Brinsupri 路 EMEA/H/C/005820 路 Authorised, authorised Nov 18, 2025 (Commission decision C(2025) 7997) 路 EPAR

Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA217673 路 INSMED INC 路 first approved Aug 12, 2025

European Union

  • Brinsupri: Authorised since Nov 18, 2025

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA217673 (Orange Book)

14 listed patents, latest expiry Feb 21, 2040
  • US 10287258 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 10669245 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 11655221 路 expires Jan 21, 2035 路 drug product, U-4257
  • US 11655222 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 11655223 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 11655224 路 expires Jan 21, 2035 路 drug product, U-4257
  • US 11673871 路 expires Jan 21, 2035 路 drug product, U-4257
  • US 11773069 路 expires Jan 21, 2035 路 drug product, U-4257
  • US 11814359 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 12054465 路 expires Jan 21, 2035 路 drug substance, U-4257
  • US 9815805 路 expires Jan 21, 2035 路 U-4257
  • US 9522894 路 expires Mar 12, 2035 路 drug substance
  • US 12201638 路 expires Mar 1, 2039 路 drug product
  • US 12059424 路 expires Feb 21, 2040 路 drug product

Exclusivity: NCE until Aug 12, 2030 路 Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 16 linked records.

Phase 1NOT YET RECRUITINGNCT07859007

A Study to Assess the Potential CYP3A Induction Effect of Brensocatib on the Pharmacokinetics (PK) of Midazolam in Healthy Participants

Insmed Incorporated 路 Updated Oct 5, 2026

Phase 2COMPLETEDNCT06013241

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

Insmed Incorporated 路 Updated Sep 30, 2026

Phase 2TERMINATEDNCT06685835

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

Insmed Incorporated 路 Updated Jun 29, 2026

Phase 2COMPLETEDNCT05090904

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

Insmed Incorporated 路 Updated Mar 12, 2026

Phase 3COMPLETEDNCT04594369

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

Insmed Incorporated 路 Updated Dec 16, 2025

N/AAPPROVED FOR MARKETINGNCT05344508

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

Insmed Incorporated 路 Updated Nov 4, 2025

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 5, 202619
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.