Brensocatib

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.

• BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.

• None. None.contraindicated

Recommended dosage: 10 mg or 25 mg orally once daily with or without food. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of BRINSUPRI is as follows: 10 mg orally once daily with or without food or 25 mg orally once daily with or without food Missed Dose(s) Patients who miss a dose should take the next dose at their regular time the next day. Do not double the dose to make up for the missed dose.

Dermatologic Adverse Reactions : Monitor for new rash or skin conditions and refer to dermatology for evaluation. ( 5.1 ) Gingival and Periodontal Adverse Reactions : Gingival and periodontal adverse reactions can occur with BRINSUPRI use. Refer to the dental care services for regular dental checkups and advise patients to perform routine dental hygiene. ( 5.2 ) Live Attenuated Vaccines : It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of the vaccines. Avoid use of live attenuated vaccines. ( 5.3 ) 5.1 Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis [see Adverse Reactions (6.1) ]. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. 5.2 Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions [see Adverse Reactions (6.1) ]. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. 5.3 Live Attenuated Vaccines The concomitant use of BRINSUPRI and live attenuated vaccines has not been evaluated. It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines.

The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions [see Warnings and Precautions (5.1) ] Gingival and Periodontal Adverse Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Insmed Incorporated at 1-844-4-INSMED or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data below reflect the safety of BRINSUPRI in adult and pediatric patients aged 12 years and older with non-cystic fibrosis bronchiectasis (NCFB). A total of 1721 patients with NCFB were randomized in a double-blind, placebo-controlled clinical trial of 52 weeks duration (ASPEN) [see Clinical Studies (14) ]. The safety of BRINSUPRI was based on data from 1719 adult and pediatric patients aged 12 years and older who received at least one dose of BRINSUPRI or placebo. A total of 1156 patients received at least one dose of BRINSUPRI 10 mg or 25 mg orally once daily. Table 1 shows the adverse reactions occurring at an incidence of ≥2% and higher in BRINSUPRI-treated patients compared to placebo in the safety population from ASPEN.

8.1 Pregnancy Risk Summary There are no available data on BRINSUPRI use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal embryo fetal development (EFD) studies, oral administration of brensocatib to pregnant rats during organogenesis at maternal exposures 128 times the maximum recommended human dose (MRHD) on an AUC basis was associated with malformations. Oral administration of brensocatib to pregnant rabbits during organogenesis demonstrated no adverse developmental effects at doses that produced maternal exposures up to 20 times the MRHD. No adverse development effects were observed after oral administration of brensocatib to pregnant rats from the period of organogenesis through lactation at doses that produced maternal exposures 17 times the MRHD on an AUC basis (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Metabolism

Following once daily administration of brensocatib 10 mg, the estimated geometric mean (CV%) C max is 85.4 ng/mL (33%) and AUC tau is 1360 ng*h/mL (41%). Following once daily administration of brensocatib 25 mg, the estimated geometric mean (CV%) C max is 259 ng/mL (31%) and AUC tau is 4060 ng*h/mL (39%).

Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

• Aug 12, 2025NDANDA217673Insmed Inc

1. 1Therapy Interrupted9612%
2. 2Cough8811%
3. 3Headache779.7%
4. 4Dyspnoea648.1%
5. 5Rash557.0%
6. 6Product Dose Omission Issue536.7%
7. 7Pneumonia526.6%
8. 8Hospitalisation516.4%
9. 9Off Label Use496.2%
10. 10Hypertension486.1%
11. 11Adverse Drug Reaction465.8%
12. 12Fatigue445.6%
13. 13Infective Exacerbation Of Bronchiectasis324.0%
14. 14Condition Aggravated313.9%
15. 15Dry Skin313.9%

The 10 most recently updated of 18 ClinicalTrials.gov registrations naming Brensocatib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
  Completed · Phase 2 · Interventional · 29 enrolled · Insmed Incorporated
  NCT05090904updated 2026-03-12
• A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)
  Active not recruiting · Phase 2 · Interventional · 214 enrolled · Insmed Incorporated
  NCT06685835updated 2026-03-06
• A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
  Completed · Phase 3 · Interventional · 1,767 enrolled · Insmed Incorporated
  NCT04594369updated 2025-12-16
• A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)
  Completed · Phase 2 · Interventional · 288 enrolled · Insmed Incorporated
  NCT06013241updated 2025-11-10
• An Expanded Access Study to Assess Brensocatib for Participants With Non-Cystic Fibrosis Bronchiectasis
  Approved for marketing · Expanded access · Insmed Incorporated
  NCT05344508updated 2025-11-04
• A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants
  Completed · Phase 1 · Interventional · 24 enrolled · Insmed Incorporated
  NCT06344728updated 2024-06-13
• A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants
  Completed · Phase 1 · Interventional · 20 enrolled · Insmed Incorporated
  NCT06178783updated 2024-01-22
• A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants
  Completed · Phase 1 · Interventional · 22 enrolled · Insmed Incorporated
  NCT05965570updated 2023-12-11
• STOP-COVID19: Superiority Trial Of Protease Inhibition in COVID-19
  Completed · Phase 3 · Interventional · 406 enrolled · University of Dundee
  NCT04817332updated 2023-08-22
• A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
  Completed · Phase 1 · Interventional · 32 enrolled · Insmed Incorporated
  NCT05826574updated 2023-08-21

Frequently asked questions

How does Brensocatib work?

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.

What is Brensocatib used for?

According to FDA labeling, Brensocatib carries indications including: BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 (DPP1) inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Brensocatib?

Brensocatib is classified as Protease Inhibitors, Serine Proteinase Inhibitors.

What are the brand names for Brensocatib?

Brensocatib is marketed under brand names including Brinsupri.

What are the contraindications for Brensocatib?

Brensocatib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.