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Research Report
GB-7624: An Investigational Anti-IL-13 Monoclonal Antibody for Atopic Dermatitis
1. Executive Summary
GB-7624 is an investigational monoclonal antibody currently under development by Generate Biomedicines, Inc..[1] Utilizing the company's proprietary artificial intelligence (AI) and machine learning platform for drug generation, GB-7624 is designed to target and inhibit Interleukin-13 (IL-13), a cytokine implicated in the pathophysiology of Type 2 inflammatory diseases.[1] The primary therapeutic indication being pursued for GB-7624 is atopic dermatitis (AD).[1] The program has advanced into clinical development, with a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled study initiated in March 2025.[1] This ongoing trial (NCT06920693 / ACTRN12625000229471), being conducted in healthy adult volunteers in Australia, aims primarily to evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending subcutaneous doses of GB-7624.[1] The progression of GB-7624 through clinical trials serves not only to evaluate the therapeutic potential of the antibody itself but also acts as an important validation point for Generate Biomedicines' AI-driven drug discovery and development platform within the competitive immunology landscape.[7] Early safety and PK data from this Phase 1 study will be critical determinants for the future development trajectory of GB-7624 and for reinforcing confidence in the underlying technology platform.
2. Introduction to GB-7624
2.1. Identification
GB-7624 is the development code name for an investigational monoclonal antibody.[1] Known synonyms include GB 7624 and GB7624.[1] It is classified as a biologic drug product.
2.2. Developer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/10 | Phase 1 | Recruiting | Generate Biomedicines |
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. | |||||