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Brinsupri (BRENSOCATIB)
Brinsupri works by inhibiting the activity of a protein that contributes to airway damage and inflammation.
Brensocatib (Brinsupri), developed by Insmed Inc, is a marketed drug specifically indicated for non-cystic fibrosis bronchiectasis, a condition with limited therapeutic options. Its key strength lies in its unique mechanism of action, inhibiting a protein that reduces airway damage and inflammation, setting it apart in the treatment landscape. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | BRENSOCATIB |
|---|---|
| Sponsor | Insmed Inc |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | FDA-approved |
| First approval | 2025 |
Mechanism of action
Brensocatib is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 activates pro-inflammatory neutrophil serine proteases (NSPs) during neutrophil maturation in the bone marrow. Activated NSPs are implicated in the pathogenesis of neutrophil-mediated NCFB inflammation. In cell-based assays, DPP1 inhibition by brensocatib reduces the activity of NSPs including neutrophil elastase, cathepsin G, and proteinase 3.
Approved indications
- non-cystic fibrosis bronchiectasis
- non-cystic fibrosis bronchiectasis
Common side effects
- Upper respiratory tract infection
- Headache
- Rash
- Dry skin
- Hyperkeratosis
- Hypertension
- Gingival and periodontal adverse reactions
- ALT >3× ULN
- AST >3× ULN
- Alkaline phosphatase >1.5× ULN
- Skin cancers
- Alopecia
Key clinical trials
- A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis (PHASE2)
- A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS) (PHASE2)
- A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (PHASE3)
- A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP) (PHASE2)
- An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
- A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants (PHASE1)
- A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants (PHASE1)
- A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Brinsupri CI brief — competitive landscape report
- Brinsupri updates RSS · CI watch RSS
- Insmed Inc portfolio CI