Brand Name
Brinsupri
Generic Name
Brensocatib
View Brand Information FDA approval date: August 12, 2025
Form: Tablet
What is Brinsupri (Brensocatib)?
BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older. BRINSUPRI is a dipeptidyl peptidase 1 inhibitor indicated for the treatment of non-cystic fibrosis bronchiectasis in adult and pediatric patients 12 years of age and older.
Approved To Treat
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Summary: The primary purpose of the study is evaluate the effect of brensocatib compared with placebo.
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Brand Information
Brinsupri (Brensocatib)
1INDICATIONS 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.
2DOSAGE FORMS AND STRENGTHS
Tablets:
- 10 mg, brown, round, film-coated tablets debossed with "10" on one side and "BRE" on the other
- 25 mg, gray, round, film-coated tablets debossed with "25" on one side and "BRE" on the other
3CONTRAINDICATIONS
None.
4ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- Dermatologic Adverse Reactions
- Gingival and Periodontal Adverse Reactions
4.1Clinical 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)
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.
5OVERDOSAGE
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.
6DESCRIPTION
BRINSUPRI (brensocatib) is a dipeptidyl peptidase 1 (DPP1) inhibitor.
The chemical name for the active ingredient brensocatib monohydrate is (2
Brensocatib monohydrate drug substance is a white to off-white solid powder. It is slightly soluble at pH 1.2, freely soluble at pH 4.5, and very slightly soluble at pH 6.8 of aqueous media. It is also soluble in acetonitrile and sparingly soluble in ethanol.
BRINSUPRI tablets are available for oral administration in strengths of 10 mg and 25 mg brensocatib with the following inactive ingredients: dibasic calcium phosphate dihydrate, glyceryl dibehenate, microcrystalline cellulose, silicon dioxide, and sodium starch glycolate. The film coating contains ferrosoferric oxide/black iron oxide, iron oxide yellow, and iron oxide red (10 mg) or ferrosoferric oxide/black iron oxide (25 mg), macrogol/PEG, polyvinyl alcohol-partially hydrolyzed, talc, and titanium dioxide.
7CLINICAL STUDIES
The efficacy of BRINSUPRI was evaluated in two randomized, double-blind, placebo-controlled, parallel-group, multicenter, multinational clinical trials (ASPEN [NCT04594369] and WILLOW [NCT03218917]).
ASPEN was a 52-week trial that included 1721 adult and pediatric patients 12 years of age and older with NCFB (1680 adults and 41 pediatric patients 12 years of age to less than 18 years of age) who were randomized to BRINSUPRI 10 mg (n=583), BRINSUPRI 25 mg (n=575), or placebo (n=563) administered orally once daily.
WILLOW was a 24-week trial that included 256 adult patients with NCFB who were randomized to BRINSUPRI 10 mg (n=82), BRINSUPRI 25 mg (n=87), or placebo (n=87) administered orally once daily.
In both ASPEN and WILLOW, all adult patients had a history of confirmed NCFB by chest computed tomography with at least 2 documented pulmonary exacerbations (PEx) prior to screening in the past 12 months. In ASPEN, pediatric patients 12 years of age and older had at least one PEx in the prior 12 months.
Demographics and baseline characteristics of patients in ASPEN and WILLOW are provided in
8HOW SUPPLIED/STORAGE AND HANDLING
BRINSUPRI (brensocatib) tablets are supplied as described in
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
10PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 71558-002-30
Brinsupri™
25 mg
30 Tablets
11PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label
NDC 71558-001-30
Brinsupri™
10 mg
30 Tablets
