Overview

Astegolimab is under investigation in clinical trial NCT04386616 (A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Oct 28, 2025

Astegolimab (DB16386): A Comprehensive Scientific and Clinical Monograph on a Novel ST2-Targeting Monoclonal Antibody

Section 1: Molecular Profile and Mechanism of Action

1.1. Identification and Structural Characteristics

Astegolimab is an investigational, fully human monoclonal antibody (mAb) of the immunoglobulin G2 (IgG2) subclass with a kappa light chain, designed as a high-affinity antagonist of the interleukin-33 (IL-33) receptor, ST2.[1] As a biotech therapeutic, it represents a targeted approach to modulating key inflammatory pathways implicated in a range of diseases. The molecule is identified by the DrugBank Accession Number DB16386 and the Chemical Abstracts Service (CAS) Number 2173054-79-8.[2]

Throughout its development, Astegolimab has been known by several codes, reflecting its journey through different corporate and research programs. These synonyms include AMG-282, MSTT1041A, RG-6149, RO-7187807, and the World Health Organization (WHO) designation 11067.[6] The complete protein sequence is of human origin, which is intended to minimize the potential for immunogenicity in patients.[3]

Continue reading the full research report

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Evaluate the Effect of Injection Site on PK of Astegolimab in Healthy Subjects	2024/06/17	NCT06462118	Phase 1	Completed	Genentech, Inc.
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)	2023/05/26	NCT05878769	Phase 3	Recruiting	Hoffmann-La Roche
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease	2022/10/27	NCT05595642	Phase 3	Recruiting	Hoffmann-La Roche
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease	2021/09/08	NCT05037929	Phase 2	Completed	Genentech, Inc.
A Study to Evaluate the Safety and Efficacy of MSTT1041A (Astegolimab) or UTTR1147A in Patients With Severe COVID-19 Pneumonia	2020/05/13	NCT04386616	Phase 2	Completed	Genentech, Inc.
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Moderate to Severe Atopic Dermatitis	2018/11/20	NCT03747575	Phase 2	Completed	Genentech, Inc.
Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP)	2018/08/03	NCT03615040	Phase 2	Completed	University of Leicester
A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma	2016/09/28	NCT02918019	Phase 2	Completed	Hoffmann-La Roche
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 282 in Healthy Subjects and Subjects With Chronic Rhinosinusitis With Nasal Polyps	2014/06/23	NCT02170337	Phase 1	Completed	Amgen
A First-in-Human, Double Blind, Single Dose Study in Healthy Subjects and Subjects With Mild Atopic Asthma.	2013/08/23	NCT01928368	Phase 1	Completed	Amgen

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.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Roche's Astegolimab Shows Mixed Results in COPD Trials, Phase IIb Study Meets Primary Endpoint

3 months ago

Roche's pivotal Phase IIb ALIENTO study met its primary endpoint, showing astegolimab reduced annualized exacerbation rate by 15.4% in COPD patients at 52 weeks.

Precision Medicine Biologics Poised to Transform $30.2 Billion COPD Market by 2033

7 months ago

• The COPD market is projected to reach $30.2 billion by 2033 across seven major markets, with biologics targeting specific patient subgroups leading the growth. • Sanofi/Regeneron's itepekimab shows promise for former smokers with COPD, demonstrating a 30% reduction in exacerbations and 110ml improvement in FEV1 in Phase II trials. • Roche's astegolimab, an anti-ST2 monoclonal antibody in Phase III development, offers a potentially stronger effect on type 2 inflammation compared to IL-33 targeting therapies.

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