Overview
No overview information available.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Published: May 12, 2025
GSK-4528287 Medication Report
Name: GSK-4528287 English Name: GSK-4528287 Drug Type: Unknown Target: Unknown Action: Unknown Mechanism: Unknown Therapeutic Areas: Immune System Diseases, Digestive System Disorders Active Indication: Ulcerative Colitis Inactive Indication: None listed Originator Organization: GSK Plc Active Organization: GSK Plc Inactive Organization: None listed License Organization: None listed Drug Highest Phase: Phase 1 First Approval Date: Not yet approved Regulation: Unknown
R&D Status
- Highest Phase: Phase 1 for Ulcerative Colitis in the United Kingdom.
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants is currently recruiting (NCT06681181).
- Estimated Primary Completion Date (NCT06681181): October 23, 2025
- Estimated Study Completion Date (NCT06681181): September 9, 2026
Clinical Trials
- NCT06681181: A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants.
- Phase: 1
- Status: Recruiting
- Enrollment: 48 participants (estimated)
- Age: 18 to 55 years
- Location: United Kingdom
- Sponsor: GlaxoSmithKline (GSK)
- Primary Outcome: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as assessed by the Investigator.
- Secondary Outcomes: Pharmacokinetic parameters (Cmax, AUCinf, tmax, half-life), assessment of target engagement biomarkers in blood.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/08 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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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
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
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| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
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| 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 |
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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 |
|---|---|---|---|---|---|
| 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. | |||||
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