Overview
Pizotifen belongs to the class of antamines and is related to cyproheptadine. It is a potent serotonin and tryptamine antagonist that has been used for migraine prevention for many years. It exhibits weak anticholinergic, antihistamine, and antikinin actions in addition to sedative and appetite-stimulating properties . Some patients receiving pizotifen treatment developed tolerance with the prolonged use of the drug . Numerous studies have revealed the potential antidepressant effects of pizotifen, which are independent of its antimigraine action . While it is suggested that pizotifen may act similarly to the classic tricyclic antidepressants , its full mechanism of antidepressant action is not fully elucidated. Pizotifen hydrochloride is an active ingredient in Sandomigran, which is used for the prophylactic management of migraines. Sandomigran is available in a number of countries but is not approved by the FDA nor EMA.
Indication
Indicated for the prophylactic management of migraines .
Associated Conditions
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2024/07/15 | Not Applicable | Recruiting | |||
2023/12/06 | Phase 2 | Active, not recruiting | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh |
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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Pizotifen Tablets | 国药准字H31021535 | 化学药品 | 片剂(糖衣) | 3/3/2020 | |
Pizotifen Tablets | 国药准字H21023242 | 化学药品 | 片剂 | 8/18/2021 |
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 |
---|---|---|---|---|---|
No TGA approvals found for this drug. |
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