Overview
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Indication
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Associated Conditions
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Research Report
Comprehensive Report on the Investigational Agent GS-0151
I. Executive Summary
GS-0151 is an investigational therapeutic antibody currently in Phase I clinical development for the treatment of Rheumatoid Arthritis (RA). Developed by Gilead Sciences following its acquisition of MiroBio, where the compound was known as MB-151, GS-0151 functions as an agonist of the Programmed Cell Death Protein 1 (PD-1) receptor.[1] This mechanism represents a novel immunomodulatory approach for autoimmune diseases, aiming to restore immune homeostasis by enhancing inhibitory signaling in hyperactive immune cells. The ongoing Phase Ib clinical trial (NCT06902519 / GS-US-667-6882) is designed to evaluate the safety, tolerability, and pharmacokinetics of GS-0151 in adult participants with RA. The acquisition of MiroBio and the subsequent advancement of GS-0151 into clinical trials, with an anticipated start in March 2025 and a primary completion date in December 2026 [2], underscore Gilead Sciences' strategic commitment to expanding its inflammation pipeline with innovative therapeutic modalities.[4] The development of GS-0151 is a tangible manifestation of this strategy, leveraging external innovation to address unmet needs in complex autoimmune conditions.
II. Introduction to GS-0151
A. Overview and Therapeutic Rationale
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/03/30 | Phase 1 | Recruiting |
FDA Drug Approvals
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| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
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| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
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| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
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| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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| No UK EMC drug information found for this drug. | |||||
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