Chemistry:Brensocatib
Brensocatib, sold under the brand name Brinsupri, is a medication used for the treatment of bronchiectasis.[1] It is a dipeptidyl peptidase 1 (DPP1) inhibitor.[1][2] It is taken by mouth.[1]
Brensocatib was approved for medical use in the United States in August 2025.[1][3]
Medical uses
Brensocatib is indicated for the treatment of non-cystic fibrosis bronchiectasis in people aged twelve years of age and older.[1]
History
Bresocatib was discovered as a second generation DPP1 inhibitor, by scientists at AstraZeneca, eliminating aorta binding liabilities found with earlier compound series.[4] A phase III clinical trial, known as the ASPEN trial, was conducted to evaluate the safety and efficacy of brensocatib in patients with non-cystic fibrosis bronchiectasis.[5]
Society and culture
Legal status
Brensocatib was approved for medical use in the United States in August 2025.[6]
In October 2025, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Brinsupri, intended for the treatment of non-cystic fibrosis bronchiectasis in people aged twelve years of age and older.[7][8] The applicant for Brinsupri is Insmed Netherlands B.V.[9] Brensocatib was authorized for medical use in the European Union in November 2025.[7][10]
Names
Brensocatib is the international nonproprietary name.[11]
Brensocatib is sold under the brand name Brinsupri.[1]
References
- ↑ 1.0 1.1 1.2 1.3 1.4 1.5 "Prescribing Information for Brensocatib". https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217673s000lbl.pdf.
- ↑ "Pharmacokinetic/Pharmacodynamic Evaluation of the Dipeptidyl Peptidase 1 Inhibitor Brensocatib for Non-cystic Fibrosis Bronchiectasis". Clinical Pharmacokinetics 61 (10): 1457–1469. October 2022. doi:10.1007/s40262-022-01147-w. PMID 35976570.
- ↑ "Novel Drug Approvals for 2025". 15 August 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025.
- ↑ "Discovery of Second Generation Reversible Covalent DPP1 Inhibitors Leading to an Oxazepane Amidoacetonitrile Based Clinical Candidate (AZD7986)". Journal of Medicinal Chemistry 59 (20): 9457-9472. October 2015. doi:10.1021/acs.jmedchem.6b01127. PMID 27690432.
- ↑ "Phase 3 Trial of the DPP-1 Inhibitor Brensocatib in Bronchiectasis". The New England Journal of Medicine 392 (16): 1569–1581. April 2025. doi:10.1056/NEJMoa2411664. PMID 40267423.
- ↑ "FDA Approves Brinsupri (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease" (Press release). Insmed. 12 August 2025. Retrieved 17 August 2025 – via PR Newswire.
- ↑ 7.0 7.1 "Brinsupri EPAR". 17 October 2025. https://www.ema.europa.eu/en/medicines/human/EPAR/brinsupri. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ "First treatment for serious chronic lung disease". European Medicines Agency (EMA) (Press release). 17 October 2025. Retrieved 27 October 2025.
- ↑ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 October 2025". 17 October 2025. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-13-16-october-2025.
- ↑ "Brinsupri PI". 19 November 2025. https://ec.europa.eu/health/documents/community-register/html/h1995.htm.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020.
External links
- Clinical trial number NCT04594369 for "A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis (ASPEN)" at ClinicalTrials.gov
- Clinical trial number NCT03218917 for "Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis" at ClinicalTrials.gov
 |  |
