Alvelestat

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
COVID-19 Study of Safety and Tolerability of Alvelestat	2020/09/07	NCT04539795	Phase 1	Completed	University of Alabama at Birmingham
MPH966 for Prevention of Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation	2019/06/14	NCT03986086	Phase 1	Withdrawn	Nelson Chao
Alvelestat (MPH966) for the Treatment of ALpha-1 ANTitrypsin Deficiency	2018/09/20	NCT03679598	Phase 2	Completed	University of Alabama at Birmingham
A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.	2018/08/17	NCT03636347	Phase 2	Completed	Mereo BioPharma
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation	2016/02/01	NCT02669251	Phase 1	Recruiting	National Cancer Institute (NCI)
Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes	2015/11/05	NCT02597101	Phase 2	Completed	Nick Giannoukakis, PhD
A Drug-Drug Interaction Study Between AZD9668 and Warfarin to Study the Effect of AZD9668 on the Metabolism and Effect of Warfarin	2010/10/04	NCT01214122	Phase 1	Withdrawn	AstraZeneca
Phase I, Exploratory, Single Centre, Single Oral Dose AZD9668 and Intravenous Microdose of [C14] AZD9668, Healthy Subject	2010/07/13	NCT01161355	Phase 1	Completed	AstraZeneca
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks in Chronic Obstructive Pulmonary Disease (COPD) Patients	2010/01/22	NCT01054170	Phase 2	Completed	AstraZeneca
AZD9668 Relative Bioavailability	2009/12/18	NCT01035411	Phase 1	Completed	AstraZeneca

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

Mereo BioPharma's Setrusumab Shows Promise in Phase II, Alvelestat Gains EMA Orphan Status

6 months ago

Phase II results for setrusumab demonstrated significant improvements in fracture rates and bone strength, supporting continued development despite initial Phase III interim analysis outcomes.

Mereo BioPharma's Setrusumab Phase 3 Trial Progresses; Alvelestat Receives Positive EMA Opinion

8 months ago

Mereo BioPharma's setrusumab Phase 3 Orbit study for osteogenesis imperfecta is ongoing, with a second interim analysis expected in mid-2025.

Setrusumab Receives FDA Breakthrough Therapy Designation for Osteogenesis Imperfecta

8 months ago

The FDA granted Breakthrough Therapy Designation to setrusumab for reducing fracture risk in osteogenesis imperfecta (OI) types I, III, and IV, for patients aged 2 years and older.

Mereo BioPharma Advances Rare Disease Pipeline with Setrusumab and Alvelestat

2 years ago

Mereo BioPharma's partner, Ultragenyx, anticipates completing enrollment for the Phase 3 Orbit study of setrusumab in Osteogenesis Imperfecta (OI) by the end of Q1 2024.

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