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MedsAcross

Molecule

Brensocatib

Available on requestRespiratory
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Brensocatib is a prescription medicine indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. It is available as tablets for oral use. MedsAcross supplies Brensocatib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
R03 Asthma and COPD medicines
US FDA first approval
12 August 2025
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 25CG88L0BBCAS 1802148-05-5DrugBank DB15638Q105334645

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

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.

Source: US FDA prescribing information

How it works

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.

Source: US FDA prescribing information

Dosing overview

Recommended dosage: 10 mg or 25 mg orally once daily with or without food. 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.

Source: US FDA prescribing information

Warnings and precautions

Dermatologic Adverse Reactions: Monitor for new rash or skin conditions and refer to dermatology for evaluation. 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. 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.

Source: US FDA prescribing information

Side effects

The following adverse reactions are described elsewhere in the labeling: Dermatologic Adverse Reactions Gingival and Periodontal Adverse Reactions Most common adverse reactions (incidence ≥2%): upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, hypertension. or https://www.fda.gov/medwatch.

Source: US FDA prescribing information

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Store in original container.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Brensocatib, sorted by availability.

MedicineManufacturerRegisterAvailability
Brinsupri 10 mg tabletOralInsmedUS FDAAvailable on request
Brinsupri 25 mg tabletOralInsmedUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 12 August 2025Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Brensocatib available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Brensocatib and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Brensocatib have?

The catalogue lists 1 brand names for Brensocatib, including Brinsupri.

Is Brensocatib approved by the US FDA?

Yes. The US FDA first approved Brensocatib on 12 August 2025, according to Drugs@FDA.

Is Brensocatib authorised in the European Union?

Yes. Brensocatib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Brensocatib need cold chain shipping?

No listed presentation of Brensocatib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Brensocatib in?

Brensocatib is classified under ATC code R03 (Asthma and COPD medicines).

References

  1. Brinsupri prescribing information (Insmed). U.S. National Library of Medicine, DailyMed. Retrieved 16 March 2026
  2. Brinsupri: European public assessment report (EPAR). European Medicines Agency. Retrieved 16 September 2026

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