Brensocatib

Overview

Brensocatib is under investigation in clinical trial NCT03218917 (Assessment of INS1007 in Subjects With Non-cystic Fibrosis Bronchiectasis).

Indication

用于非囊性纤维化支气管扩张症（NCFBE）成人患者的治疗。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study of the Efficacy and Safety of Brensocatib in Adults With Moderate to Severe Hidradenitis Suppurativa (HS)	2024/11/13	NCT06685835	Phase 2	Recruiting	Insmed Incorporated
A Study to Assess the Relative Bioavailability of Brensocatib Pediatric Oral Solution to Oral Tablets in Healthy Participants	2024/04/03	NCT06344728	Phase 1	Completed	Insmed Incorporated
A Study of the Palatability and Acceptability of Different Brensocatib Oral Liquid Formulations in Healthy Participants	2023/12/21	NCT06178783	Phase 1	Completed	Insmed Incorporated
A Study of the Efficacy and Safety of Brensocatib in Participants With Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)	2023/08/28	NCT06013241	Phase 2	Active, not recruiting	Insmed Incorporated
A Study to Investigate Effect of Clarithromycin, a Strong CYP3A4 Inhibitor, on Brensocatib Pharmacokinetics in Healthy Participants	2023/07/28	NCT05965570	Phase 1	Completed	Insmed Incorporated
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of INS1007 in Healthy Japanese and Caucasian Participants	2023/07/03	NCT05927597	Phase 1	Completed	Insmed Incorporated
A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants	2023/04/24	NCT05826574	Phase 1	Completed	Insmed Incorporated
A Study of Brensocatib Following a Single Oral Administration in Participants With or Without Renal Impairment	2023/01/06	NCT05673603	Phase 1	Completed	Insmed Incorporated
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment	2022/08/26	NCT05517525	Phase 1	Completed	Insmed Incorporated
A Study to Investigate the Effects of Brensocatib on QT Interval in Healthy Participants	2022/05/02	NCT05355935	Phase 1	Completed	Insmed Incorporated

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Non-Cystic Fibrosis Bronchiectasis Market Expected to Reach USD 7.5 Billion by 2035, Driven by Novel Therapies

4 months ago

The Non-Cystic Fibrosis Bronchiectasis (NCFB) market is projected to grow from USD 1.7 billion in 2024 to USD 7.5 billion by 2035, representing a robust CAGR of 14.62%.

EMA Evaluates Fast-Track Status for Three Novel Therapeutics from Scholar, Insmed, and Soleno

5 months ago

• The European Medicines Agency is reviewing accelerated assessment requests for three innovative drugs - apitegromab, brensocatib, and diazoxide choline - based on their potential major public health impact. • Scholar Rock's apitegromab, Insmed's brensocatib, and Soleno's diazoxide choline are being evaluated for their therapeutic innovation potential in addressing significant unmet medical needs. • The fast-track designation, if granted, would expedite the regulatory review process for these promising therapeutics, potentially bringing them to patients more quickly.

FDA Grants Priority Review to Brensocatib for Non-Cystic Fibrosis Bronchiectasis Treatment

5 months ago

The FDA has accepted Insmed's New Drug Application for brensocatib, setting a PDUFA target action date of August 12 under Priority Review designation.

Insmed's Brensocatib NDA Accepted by FDA with Priority Review; Anticipated Launch in Q3 2025

6 months ago

The FDA has accepted Insmed's New Drug Application for brensocatib in bronchiectasis, granting Priority Review with a PDUFA target action date of August 12, 2025.

NCFB Pipeline Shows Promise with Over 15 Companies Developing New Therapies

8 months ago

• The non-cystic fibrosis bronchiectasis (NCFB) market is experiencing growth due to rising prevalence and increased awareness, leading to early diagnosis and treatment. • Over 15 companies are actively developing more than 15 NCFB drugs, aiming to improve the treatment landscape for this chronic lung condition. • Key players like Insmed, AstraZeneca, and Verona Pharma are advancing promising therapies such as brensocatib, benralizumab and ensifentrine through clinical trials. • Recent clinical trial milestones, including Phase III results for brensocatib and Phase II enrollment for AP-PA02, signal progress in addressing unmet needs in NCFB treatment.

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