Overview
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Indication
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Research Report
Fipravirimat (GSK3640254): A Comprehensive Monograph on a Next-Generation HIV-1 Maturation Inhibitor and its Strategic Discontinuation
Section 1: Executive Summary and Compound Profile
1.1. Overview
[Fipravirimat, also known by its developmental codes GSK3640254 and BMS 986197, represents a significant chapter in the pursuit of novel antiretroviral therapies for Human Immunodeficiency Virus Type 1 (HIV-1). As an orally administered small molecule, Fipravirimat belongs to the investigational class of HIV-1 maturation inhibitors (MIs), agents designed to disrupt the final stages of the viral lifecycle. The drug was originated by Bristol Myers Squibb (BMS) and subsequently advanced through a comprehensive clinical development program by ViiV Healthcare, a specialist HIV company majority-owned by GSK.]
[The compound demonstrated potent, dose-dependent antiviral activity in early clinical studies, successfully engaging its target and validating its novel mechanism of action. This mechanism, termed sub-stoichiometric modulation, allowed a small number of drug molecules to disrupt the entire cooperative assembly of the viral Gag polyprotein shell, leading to high intrinsic potency. Fipravirimat was specifically engineered to overcome the limitations of previous-generation MIs, showing broad activity against HIV-1 strains with baseline Gag polymorphisms that had rendered earlier compounds ineffective.]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/05/25 | Phase 2 | Terminated | |||
2021/04/23 | Phase 1 | Completed | |||
2020/11/16 | Phase 1 | Completed | |||
2020/09/25 | Phase 1 | Completed | |||
2020/07/30 | Phase 2 | Terminated | |||
2019/06/13 | Phase 1 | Completed | |||
2019/02/11 | Phase 1 | Completed | |||
2019/01/25 | Phase 1 | Completed | |||
2018/12/21 | Phase 2 | Completed | |||
2017/07/27 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| 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 |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| 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 |
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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
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
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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 |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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