Overview
Varlitinib is an oral, selective, reversible, small molecule tyrosine kinase inhibitor of both ErbB-2 (Her-2/neu) and EGFR. Over-expression of ErbB-2 and EGFR receptors in tumors is predictive of poor prognosis in cancer patients. Varlitinib has shown significant anti-tumor activity in preclinical models of human breast, lung, and epidermal carcinoma tumors.
Indication
Investigated for use/treatment in cancer/tumors (unspecified).
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Monograph on Fenfluramine (DB00574)
Executive Summary
Fenfluramine represents a molecule of profound duality in modern pharmacology, embodying a paradoxical journey from a widely proscribed anorectic agent to a highly valued anticonvulsant for rare and catastrophic pediatric epilepsies. Initially approved for obesity and later gaining notoriety as one half of the "Fen-Phen" combination, its widespread use was abruptly halted in 1997 due to an unacceptable risk of potentially fatal valvular heart disease (VHD) and pulmonary arterial hypertension (PAH). This cardiotoxicity was mechanistically linked to the activation of serotonin 5-HT2B receptors on cardiac valve fibroblasts. For over two decades, Fenfluramine was relegated to the annals of cautionary pharmaceutical tales.
However, a deeper understanding of its complex pharmacology has led to its remarkable resurrection. Fenfluramine exerts its effects through a multi-modal mechanism, acting not only as a potent serotonin releasing agent but also as a direct agonist at specific serotonin receptor subtypes (notably 5-HT1D and 5-HT2C) and as a positive modulator of the sigma-1 (σ1) receptor. This combination of enhanced inhibitory neurotransmission and dampened excitatory signaling provides a powerful, network-stabilizing effect. Recognizing this potential, researchers repurposed Fenfluramine at significantly lower doses for the treatment of intractable seizures.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/09/10 | Not Applicable | Terminated | National Cancer Centre, Singapore | ||
2018/04/17 | Phase 1 | UNKNOWN | |||
2017/12/11 | Phase 1 | Completed | |||
2017/07/27 | Phase 2 | Completed | |||
2017/04/26 | Phase 2 | Completed | |||
2017/04/26 | Phase 2 | Withdrawn | |||
2017/03/28 | Phase 2 | Completed | |||
2017/03/17 | Phase 1 | Completed | |||
2016/12/14 | Phase 1 | Terminated | |||
2016/01/07 | Phase 1 | 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
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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