Chemistry:Brensocatib

From HandWiki

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] and in the European Union in November 2025.[4][5] The US Food and Drug Administration considers it to be a first-in-class medication.[6]

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.[7] 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.[8]

Society and culture

Brensocatib was approved for medical use in the United States in August 2025.[9]

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.[4][10] The applicant for Brinsupri is Insmed Netherlands B.V.[11] Brensocatib was authorized for medical use in the European Union in November 2025.[4][5]

Names

Brensocatib is the international nonproprietary name.[12]

Brensocatib is sold under the brand name Brinsupri.[1]

References

  1. ↑ 1.0 1.1 1.2 1.3 1.4 1.5 Cite error: Invalid <ref> tag; no text was provided for refs named Brinsupri FDA label
  2. ↑ "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. 
  3. ↑ "Novel Drug Approvals for 2025". 15 August 2025. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2025. 
  4. ↑ 4.0 4.1 4.2 "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.
  5. ↑ 5.0 5.1 "Brinsupri PI". 19 November 2025. https://ec.europa.eu/health/documents/community-register/html/h1995.htm. 
  6. ↑ "Advancing Health Through Innovation: New Drug Therapy Approvals 2025" (PDF). January 2026. https://www.fda.gov/media/190705/download. 
  7. ↑ "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. 
  8. ↑ "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. 
  9. ↑ "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.
  10. ↑ "First treatment for serious chronic lung disease". European Medicines Agency (EMA) (Press release). 17 October 2025. Retrieved 27 October 2025.
  11. ↑ "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. 
  12. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 83". WHO Drug Information 34 (1). 2020. 
  • 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



Retrieved from "https://handwiki.org/wiki/index.php?title=Chemistry:Brensocatib&oldid=4583353"