Overview
Enobosarm has been used in trials studying the treatment of Stress Urinary Incontinence and Triple Negative Breast Cancer.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Report on JYP-0061: An Investigational Oral Small Molecule for Autoimmune Disorders
I. Executive Summary
This report provides a comprehensive analysis of JYP-0061, an investigational therapeutic agent developed by Guangzhou JOYO Pharma Co., Ltd. JYP-0061 is an orally administered small molecule currently in Phase 2 clinical development for the treatment of multiple autoimmune diseases, with primary programs in moderate-to-severe atopic dermatitis (AD) and acute neuromyelitis optica spectrum disorder (NMOSD).[1]
While publicly available drug development databases currently list the mechanism of action (MoA) for JYP-0061 as "Unknown," a detailed analysis of the originator's intellectual property portfolio strongly indicates that the compound is a pyrrolopyrimidine-based Janus kinase (JAK) inhibitor, designed to target JAK1 and/or JAK2.[3] This MoA provides a robust scientific rationale for its application in the target indications, as the JAK-STAT signaling pathway is a critical mediator of the inflammatory cytokines implicated in the pathophysiology of these diseases.
The clinical development strategy for JYP-0061 is multifaceted, targeting two distinct therapeutic areas with different competitive dynamics. In the atopic dermatitis market, JYP-0061 is positioned to compete in a crowded field that includes a dominant biologic therapy and several approved oral JAK inhibitors. Success in this indication will be contingent upon demonstrating a superior, or at least highly competitive, safety and efficacy profile, a significant challenge reflected in a comparatively low third-party probability of success estimate of 12%.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/02/28 | Phase 2 | Completed | |||
2021/10/04 | Phase 3 | Terminated | |||
2021/05/03 | Phase 3 | Terminated | |||
2018/06/25 | Phase 2 | Withdrawn | |||
2018/04/26 | Phase 2 | Withdrawn | |||
2017/08/29 | Phase 1 | Completed | |||
2017/08/07 | Phase 2 | Completed | |||
2016/11/23 | Phase 2 | Completed | City of Hope Medical Center | ||
2016/01/18 | Phase 2 | Completed | |||
2015/06/04 | Phase 2 | Completed |
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 |
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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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