Clinical Trials

Brensocatib has been evaluated across multiple Phase 1, Phase 2, and Phase 3 clinical trials sponsored by entities such as Insmed Incorporated and the University of Dundee. These studies evaluate indications including non-cystic fibrosis bronchiectasis, cystic fibrosis, hidradenitis suppurativa, chronic rhinosinusitis without nasal polyps, and COVID-19, as well as pharmacokinetics in healthy volunteers and individuals with renal or hepatic impairment. While the majority of trials are completed, overall study statuses range from completed to terminated, reflecting both advanced therapeutic development and ongoing safety evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06685835 TERMINATED
Hidradenitis Suppurativa
Insmed Incorporated
 2024-12-16 PHASE2
NCT06013241 COMPLETED
Chronic Rhinosinusitis Without Nasal Polyps
Insmed Incorporated
 2023-10-30 PHASE2
NCT04594369 COMPLETED
Non-Cystic Fibrosis Bronchiectasis
Insmed Incorporated
 2020-12-01 PHASE3
NCT06344728 COMPLETED
Healthy Participants
Insmed Incorporated
 2024-04-30 PHASE1
NCT06178783 COMPLETED
Healthy Volunteers
Insmed Incorporated
 2023-12-27 PHASE1
NCT05965570 COMPLETED
Healthy Volunteers
Insmed Incorporated
 2023-07-28 PHASE1
NCT05826574 COMPLETED
Healthy Volunteers
Insmed Incorporated
 2023-05-10 PHASE1
NCT05517525 COMPLETED
Hepatic Impairment
Insmed Incorporated
 2022-10-04 PHASE1
NCT05673603 COMPLETED
Renal Impairment
Insmed Incorporated
 2021-07-20 PHASE1
NCT05090904 COMPLETED
Cystic Fibrosis
Insmed Incorporated
 2021-11-30 PHASE2
NCT05355935 COMPLETED
Healthy Volunteer
Insmed Incorporated
 2022-04-27 PHASE1
NCT05652257 COMPLETED
Healthy Volunteers
Insmed Incorporated
 2021-08-13 PHASE1
NCT04817332 COMPLETED
Covid19
University of Dundee
 2020-06-05 PHASE3
NCT03218917 COMPLETED
Non-Cystic Fibrosis Bronchiectasis
Insmed Incorporated
 2017-10-31 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Brensocatib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Brensocatib acts as a selective, reversible inhibitor of dipeptidyl peptidase-1 (DPP-1), preventing the activation of major neutrophil serine proteases—including neutrophil elastase, proteinase 3, and cathepsin G—during neutrophil maturation in the bone marrow. By attenuating the activity of these destructive enzymes prior to systemic release, the compound suppresses neutrophil-driven tissue injury, providing therapeutic relevance in clinical conditions such as non-cystic fibrosis bronchiectasis and cystic fibrosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.