BRINSUPRI (brensocatib)
Brinsupri treats non-cystic fibrosis bronchiectasis (NCFB) in both adults and pediatric patients aged 12 and older. This medication helps manage the chronic inflammation associated with the condition by targeting specific enzymes involved in the immune response. It is used to address the underlying inflammatory processes that contribute to the lung damage seen in these patients.
How BRINSUPRI Works
Brinsupri works by blocking dipeptidyl peptidase 1 (DPP1), an enzyme responsible for activating inflammatory proteins during the maturation of white blood cells in the bone marrow. By inhibiting this enzyme, the drug reduces the activity of several proteases, such as neutrophil elastase, that drive lung inflammation. This reduction in enzyme activity helps limit the neutrophil-mediated inflammation characteristic of non-cystic fibrosis bronchiectasis.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-08-12
- Patent Cliff
- 2040
- Routes
- ORAL
- Dosage Forms
- TABLET
BRINSUPRI Approval History
What BRINSUPRI Treats
1 indicationsBRINSUPRI is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Bronchiectasis
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05090904 results posted | INS1007-211 | Ph 2 | completed | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis |
| NCT06685835 CEDAR | INS1007-231 2024-515959-38-00 | Ph 2 | active not recruiting | A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS) |
| NCT06013241 BiRCh | INS1007-221 2022-502481-24-00 | Ph 2 | completed | A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) |
| NCT06178783 | INS1007-107 8521537 | Ph 1 | completed | A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants |
| NCT05965570 | INS1007-109 | Ph 1 | completed | A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants |
| NCT04817332 STOP-COVID19 results posted | 01.01.20 2020-001643-13, 281986 | Ph 3 | completed | STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19 |
| NCT05826574 | INS1007-106 | Ph 1 | completed | A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants |
| NCT05517525 | INS1007-105 | Ph 1 | completed | 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 |
| NCT05673603 | INS1007-102 | Ph 1 | completed | A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment |
| NCT05355935 | INS1007-104 | Ph 1 | completed | A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BRINSUPRI FDA Label Details
Indications & Usage
FDA Label (PDF)BRINSUPRI is indicated for the treatment of Bronchiectasis.
BRINSUPRI Patents & Exclusivity
Patents (14 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BRINSUPRI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2040
- • 56 active patents
Trial Analysis
- • 10 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment