Overview
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Research Report
Camlipixant (BLU-5937): A Comprehensive Clinical and Strategic Analysis of a Best-in-Class P2X3 Antagonist for Refractory Chronic Cough
Executive Summary
Camlipixant, formerly known as BLU-5937, is a late-stage, highly selective P2X3 receptor antagonist under development for the treatment of Refractory Chronic Cough (RCC). RCC represents a significant unmet medical need, characterized by a debilitating, persistent cough for which there are currently no approved therapies in the United States or the European Union.[1] The clinical development program for camlipixant is anchored by the positive results of the Phase IIb SOOTHE trial, which demonstrated a statistically significant and clinically meaningful 34% placebo-adjusted reduction in 24-hour cough frequency at the 50 mg and 200 mg twice-daily doses.[3]
The primary competitive advantage and defining characteristic of camlipixant is its exceptional safety and tolerability profile. This is highlighted by a very low incidence of taste-related adverse events (≤6.5%), a key differentiator from the first-generation P2X3 antagonist, gefapixant, which is hampered by high rates of taste disturbance.[3] This superior profile is a direct result of camlipixant's high molecular selectivity for the P2X3 receptor implicated in cough over the P2X2/3 receptor associated with taste.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/01/25 | Phase 1 | Completed | Bellus Health Inc. - a GSK company | ||
2023/12/22 | Phase 1 | Completed | Bellus Health Inc. - a GSK company | ||
2023/07/25 | Phase 1 | Completed | Bellus Health Inc. - a GSK company | ||
2023/06/12 | Phase 1 | Completed | Bellus Health Inc. - a GSK company | ||
2022/10/31 | Phase 3 | Active, not recruiting | Bellus Health Inc. - a GSK company | ||
2022/10/31 | Phase 3 | Recruiting | Bellus Health Inc. - a GSK company | ||
2021/01/05 | Phase 2 | Completed | Bellus Health Inc. - a GSK company | ||
2020/12/21 | Phase 2 | Completed | Bellus Health Inc. - a GSK company | ||
2019/06/07 | Phase 2 | Terminated | Bellus Health Inc. - a GSK company | ||
2018/08/20 | Phase 1 | Completed | Bellus Health Inc. - a GSK company |
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
Approved Product | Authorization Holder | Status | Issued Date |
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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 |
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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
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 |
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No UK EMC drug information found for this drug. |
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