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Dapoxetine | CAS No: 119356-77-3 | GMP-certified suppliers
A medication that treats premature ejaculation by increasing ejaculatory latency through selective serotonin reuptake inhibition, requiring high-quality API with thorough regulatory compliance documentation.
Therapeutic categories
Primary indications
- For the treatment of premature ejaculation
Product Snapshot
- Dapoxetine is an oral small molecule formulation available primarily as coated and film-coated tablets
- It is indicated for the treatment of premature ejaculation
- The compound is currently in an investigational status without regulatory approval from major agencies
Clinical Overview
Pharmacodynamically, dapoxetine acts by inhibiting the neuronal reuptake of serotonin, thereby enhancing serotonergic activity within the central nervous system. This effect modulates the spinal and cerebral ejaculatory neural circuits, which are regulated by multiple serotonin receptor subtypes including 5-HT(1A), 5-HT(1B), and 5-HT(2C). Serotonin exerts an inhibitory influence on ejaculation, and dapoxetine’s mechanism capitalizes on this pathway to delay ejaculation.
The pharmacokinetic profile of dapoxetine is distinct from other SSRIs used primarily in depression. It has a rapid absorption with time to maximum serum concentration of approximately one hour and a short elimination half-life of 1 to 2 hours. These properties enable dapoxetine’s use in an on-demand regimen rather than continuous daily dosing. It is metabolized by cytochrome P450 enzymes including CYP2D6 and CYP3A4, acting as both substrate and weak inhibitor, which may have implications for drug-drug interactions.
Safety considerations include a risk of side effects commonly associated with SSRIs such as nausea, headache, dizziness, and potential psychiatric or dermatological reactions. Long-term safety data remain limited, and regulatory approval has been variable; a New Drug Application submitted to the FDA in 2004 received a non-approvable letter in 2005, with ongoing evaluation of benefit-risk balance. Dapoxetine is labeled investigational and not globally approved at this time.
When sourcing dapoxetine API, strict adherence to pharmacopeial quality standards is critical given its pharmacological potency and metabolic profile. Suppliers should provide comprehensive documentation including impurity profiles, stability data, and compliance with relevant regulatory guidelines to ensure consistent, high-quality material suitable for clinical or commercial development.
Identification & chemistry
| Generic name | Dapoxetine |
|---|---|
| Molecule type | Small molecule |
| CAS | 119356-77-3 |
| UNII | GB2433A4M3 |
| DrugBank ID | DB04884 |
Pharmacology
| Summary | Dapoxetine is a selective serotonin reuptake inhibitor targeting 5-HT1A, 5-HT1B, and 5-HT2C receptors involved in the central neural pathways regulating ejaculation. By inhibiting serotonin reuptake, it enhances serotonergic activity, which exerts an inhibitory effect on the ejaculatory reflex via spinal and cerebral circuits. This short-acting pharmacodynamic profile distinguishes it from other SSRIs and underpins its therapeutic use in premature ejaculation. |
|---|---|
| Mechanism of action | The drug's mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes (5-HT(1A), 5-HT(1B), and 5-HT(2C)) have been postulated to mediate 5-HT's modulating activity on ejaculation. |
| Pharmacodynamics | Dapoxetine is a selective serotonin reuptake inhibitor currently undergoing trials through Alza (under license from GenuPro, a collaboration between Eli Lilly and PPD). Dapoxetine is a short-acting SSRI drug currently being considered for approval by the Food and Drug Administration (FDA) for the treatment of premature ejaculation in men, which would make it the first drug approved for such treatment. Despite two clinical trials finished in 2006, experts doubt it will be approved by the FDA soon because SSRIs come with undesirable side-effects after long-term use, such as psychiatric problems, dermatological reactions, increase in body weight, lower sex-drive, nausea, headache, upset stomach and weakness, thus not significantly outweighing the benefit of premature ejaculation medication versus the risks. By contrast with SSRIs approved for depression, which take 2 weeks or longer to reach steady-state concentration, dapoxetine has a unique pharmacokinetic profile, with a short time to maximum serum concentration (about 1 h) and rapid elimination (initial half-life of 1-2 h). |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 1A | Humans | |
| 5-hydroxytryptamine receptor 1B | Humans | |
| 5-hydroxytryptamine receptor 2C | Humans |
ADME / PK
| Absorption | Rapidly absorbed. |
|---|---|
| Half-life | Initial half-life of 1-2 hours. |
Formulation & handling
- Dapoxetine is a small molecule oral drug typically formulated as coated or film-coated tablets.
- The compound has low water solubility and a high logP, indicating limited aqueous solubility and potential formulation challenges.
- No specific food sensitivity is noted, but stability during oral administration requires consideration of tablet coating integrity.
Regulatory status
Dapoxetine is a type of Selective Serotonin Reuptake Inhibitors (SSRIs)
Selective Serotonin Reuptake Inhibitors (SSRIs) are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used for the treatment of various mental health disorders, particularly depression and anxiety. SSRIs work by inhibiting the reuptake of serotonin, a neurotransmitter that plays a crucial role in regulating mood, emotions, and well-being.
These medications are designed to selectively target the serotonin transporter proteins in the brain, preventing the reabsorption of serotonin into the presynaptic neuron. By blocking the reuptake process, SSRIs increase the concentration of serotonin in the synaptic cleft, enhancing its availability for binding to postsynaptic receptors. This ultimately leads to an improved transmission of serotonin signals between neurons.
The mechanism of action of SSRIs helps to alleviate symptoms of depression and anxiety by stabilizing mood, reducing feelings of sadness, enhancing motivation, and promoting a sense of calmness. The exact therapeutic effects and onset of action may vary depending on the specific SSRIs used.
SSRIs have gained popularity due to their favorable safety profile and efficacy in treating a range of mental health conditions. Common SSRIs include fluoxetine, sertraline, citalopram, and escitalopram. These medications are typically available in oral dosage forms, such as tablets or capsules.
It's important to note that SSRIs should be prescribed and monitored by healthcare professionals, as they can have potential side effects and interactions with other medications. Individuals considering SSRIs should consult with their healthcare provider to determine the most appropriate treatment option for their specific needs.
Dapoxetine API manufacturers & distributors
Compare qualified Dapoxetine API suppliers worldwide. We currently have 10 companies offering Dapoxetine API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 235 products |
| Dr. Sahu's Laboratories | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, MSDS | 70 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Ind-Swift Labs. | Producer | India | India | CoA, GMP, WC | 27 products |
| Janssen Pharma | Producer | Belgium | Unknown | CoA, USDMF | 63 products |
| Jiangxi Aifeimu Technolog... | Producer | China | China | CoA | 7 products |
| Maithri Drugs | Producer | India | India | CoA, WC | 12 products |
| Symed Labs | Producer | India | India | CoA, GMP, WC | 28 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
When sending a request, specify which Dapoxetine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Dapoxetine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
