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Research Report
An Investigative Analysis of the "INOC-001" Designation: Profiles of Four Distinct Investigational Therapeutics
Executive Summary
An inquiry into the investigational drug designated "INOC-001" reveals a critical finding: the designation does not refer to a single, unique therapeutic agent. Instead, it serves as a homonym for at least four distinct and unrelated drug candidates from different developers, each with its own unique scientific basis, clinical indication, and development trajectory. The conflation of these assets within public-domain pharmaceutical databases underscores the necessity of rigorous, primary-source-based due diligence in the biopharmaceutical sector. This report provides a definitive disambiguation of these entities and delivers a comprehensive profile and strategic assessment of each.
The identified assets are:
- Avantogen Oncology's INOC-001: A small molecule drug developed for the treatment of neoplasms. The program reached Phase 2 clinical trials but is now considered inactive. Its development was likely halted as a direct consequence of the 2009 clinical trial failure of the company's lead asset, RP101, which precipitated the originator's financial collapse. This asset serves as a cautionary case study in portfolio concentration risk within small biotechnology firms.
- Insignis Therapeutics' IN-001: An early-stage, needle-free sublingual spray formulation of an epinephrine prodrug for the emergency treatment of anaphylaxis. Granted Fast Track designation by the U.S. Food and Drug Administration (FDA), its primary value proposition lies in its novel delivery mechanism, which addresses needle phobia, and its unprecedented temperature stability, which solves a major logistical and economic burden associated with current auto-injectors.
- Imunon Inc.'s IMNN-001: A late-stage DNA-based immunotherapy for advanced ovarian cancer, currently preparing for a pivotal Phase 3 trial. Leveraging a proprietary nanoparticle deli
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/25 | Early Phase 1 | Recruiting | |||
2022/09/30 | Phase 4 | Recruiting | |||
2022/03/31 | Not Applicable | UNKNOWN | |||
2020/08/31 | N/A | Completed | |||
2020/01/18 | Phase 1 | Recruiting | Yali Hu | ||
2019/01/29 | Phase 2 | Completed | |||
2017/04/19 | Phase 4 | UNKNOWN | |||
2015/04/17 | Phase 3 | Completed | |||
2013/04/17 | Phase 4 | Completed | |||
2011/02/15 | Phase 4 | Completed | Rio de Janeiro State University |
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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