Dapoxetine
- Generic Name
- Dapoxetine
- Drug Type
- Small Molecule
- Chemical Formula
- C21H23NO
- CAS Number
- 119356-77-3
- Unique Ingredient Identifier
- GB2433A4M3
Overview
Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Background
Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Indication
For the treatment of premature ejaculation.
Associated Conditions
- Premature Ejaculation
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2005/09/21 | Phase 3 | Completed | Alza Corporation, DE, USA |
FDA Approved Products
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EMA Approved Products
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HSA Approved Products
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NMPA Approved Products
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Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
国药准字H20249570 | 片剂 | N/A | 30mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2024/12/01 | Domestic | ||
国药准字H20249684 | 片剂 | N/A | 30mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2024/12/06 | Domestic | ||
国药准字H20243544 | 片剂 | N/A | 30mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2024/04/17 | Domestic | ||
国药准字H20243216 | 片剂 | N/A | 30mg(按C₂₁H₂₃NO计) | Chemical Drug | Approved | 2024/02/23 | Domestic | ||
国药准字H20244118 | 片剂 | N/A | 60mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2024/06/25 | Domestic | ||
国药准字H20223926 | 片剂 | N/A | 30mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2022/12/30 | Domestic | ||
国药准字H20203553 | 片剂 | N/A | 60mg(按C21H23NO计) | Chemical Drug | Approved | 2020/11/04 | Domestic | ||
国药准字H20234541 | 片剂 | N/A | 30mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2023/11/21 | Domestic | ||
国药准字H20234684 | 片剂 | N/A | 60mg（按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2023/12/26 | Domestic | ||
国药准字H20234304 | 片剂 | N/A | 30mg(按C₂₁H₂₃NO计） | Chemical Drug | Approved | 2023/10/18 | Domestic |
PPB Approved Products
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TGA Approved Products
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