Dapoxetine hydrochloride, a short-acting selective serotonin reuptake inhibitor and a small molecule, not a peptide. Its effect on ejaculatory latency is presumed to come from inhibiting serotonin reuptake. Approved as Priligy for premature ejaculation in several European countries, and not FDA-approved.
For research purposes only. Not medical advice.
Dapoxetine is a selective serotonin reuptake inhibitor (SSRI), not a peptide. Its PubChem name, (1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenylpropan-1-amine, describes a single enantiomer built on naphthalene and phenyl rings, with no amino acids in the structure. PeptideScouter catalogues it under Sexual Health by mechanism, for its studied effect on ejaculatory latency. It shares no chemistry with the melanocortin peptides beside it, such as PT-141.
PubChem lists the free base as C21H23NO at 305.4 g/mol (CAS 119356-77-3) and the hydrochloride as C21H24ClNO at 341.9 g/mol (CAS 129938-20-1). The CAS number PeptideScouter carries is the hydrochloride's, the salt the licensed tablets contain, and the free base is about 89% of its mass. The EU summary of product characteristics (SmPC) states tablet strength as dapoxetine hydrochloride "equivalent to" an amount of dapoxetine, so the licensed label's figures refer to the free base, not the salt.
The SmPC calls dapoxetine a potent SSRI whose major human metabolites, desmethyldapoxetine and didesmethyldapoxetine, are of equivalent or lower potency. It describes ejaculation as primarily sympathetic, starting from a spinal reflex centre mediated by the brain stem, and reports that in the rat dapoxetine inhibits the ejaculatory expulsion reflex at a supraspinal level, in the lateral paragigantocellular nucleus.
Its short action shows in the SmPC's pharmacokinetics, with an initial half-life of about 1.5 hours, plasma levels below 5% of peak by 24 hours, and a terminal half-life of about 19 hours. The EMA's 2012 assessment report says dapoxetine was developed for premature ejaculation after reports of ejaculatory delay in patients taking SSRIs for depression, and because of its rapid onset and elimination.
The SmPC rests efficacy on five double-blind, placebo-controlled trials that randomised 6,081 men, with stopwatch-timed intravaginal ejaculatory latency time (IELT) among the key endpoints.
Two identical 12-week US trials sponsored by ALZA Corporation (NCT00211107 and NCT00211094) were pooled in a prospectively defined intention-to-treat analysis of 2,614 men (Pryor and colleagues, Lancet 2006). Mean IELT rose from about 0.9 minutes at baseline to 2.78 and 3.32 minutes at the two doses tested, against 1.75 minutes on placebo, at week 12 or the final visit.
A 24-week trial in 22 countries sponsored by Johnson & Johnson Pharmaceutical Research & Development (NCT00229073) enrolled 1,162 men, and 618 completed it (Buvat and colleagues, European Urology 2009). The arithmetic mean of average IELT rose from 0.9 minutes to 3.2 and 3.5 minutes at the two doses, against 1.9 on placebo, at study end point. The EMA assessment calls the geometric mean a more appropriate summary for IELT, and on that basis the trial reported a rise from 0.7 minutes to 1.8 and 2.3, against 1.1 on placebo.
Sweden authorised Priligy on February 6, 2009, and mutual recognition extended it first to Austria, Finland, Germany, Italy, Portugal and Spain. A second wave, across 22 more countries, stalled when France, Ireland, the Netherlands and the United Kingdom objected that the higher of the two strengths added too little benefit for its higher rate of syncope. The EMA's human-medicines committee concluded on October 20, 2011 that the benefit-risk balance of both strengths is positive, and the European Commission decision followed on January 20, 2012.
Syncope was the safety signal. In the phase 3 program it occurred in 0.06% and 0.23% of men at the two doses, against 0.05% on placebo, and Holter monitoring recorded bradycardia and asystole during episodes, which the assessment reads as vasovagal.
In the United States, Drugs@FDA returns no application for dapoxetine or Priligy (checked October 22, 2026). Dapoxetine is also absent from the 503A nomination category lists dated 27 September 2024 and 14 May 2026, the 503B list, the Category 2 safety-risk page and the 2024 and 2026 PCAC meeting materials, so the bulk-substance arc on the peptide pages does not apply to it. FDA's Health Fraud Product Database names it as an undeclared ingredient in consumer products, in entries dated 2013 to 2019.
The SmPC (revised September 2025, published by Ireland's regulator) limits the indication to men aged 18 to 64 with a diagnosis of premature ejaculation and says safety has not been established in men without one. It contraindicates dapoxetine in men with significant heart conditions, a history of syncope, mania or severe depression, or moderate or severe liver impairment. It also requires an orthostatic test of blood pressure and pulse before treatment starts.
No. Dapoxetine is a small-molecule selective serotonin reuptake inhibitor (SSRI), C21H23NO as the free base, with no amino acids in its structure. PeptideScouter lists it in the Sexual Health category by mechanism, for its studied effect on ejaculatory latency, not because it shares any chemistry with the peptides there.
Dapoxetine hydrochloride is the salt form, and it is what the licensed Priligy tablets contain. PubChem gives the free base as C21H23NO at 305.4 g/mol and the hydrochloride as C21H24ClNO at 341.9 g/mol, so the free base is about 89% of the salt's mass. The EU product information states tablet strength as the equivalent amount of dapoxetine free base, not the weight of the salt.
The key endpoints were intravaginal ejaculatory latency time, timed with a stopwatch, and patient-reported measures such as control over ejaculation and personal distress. An integrated analysis of the five randomized, placebo-controlled phase 3 trials, sponsored by ALZA Corporation and Johnson & Johnson Pharmaceutical Research & Development (6,081 men, McMahon and colleagues, Journal of Sexual Medicine 2011), reported that the arithmetic mean of average latency rose from 0.9 minutes at baseline to 3.1 and 3.6 minutes at week 12 at the two doses tested, against 1.9 minutes on placebo.
While Priligy's authorisation was being extended from Sweden to 22 more European countries, France, Ireland, the Netherlands and the United Kingdom objected that the higher of its two strengths added too little benefit to justify a higher rate of fainting (syncope) seen in the trials. The dispute went to the EMA's human-medicines committee, which concluded in October 2011 that the benefit-risk balance of both strengths is positive and judged the syncope risk manageable with the risk-minimisation measures in place. The European Commission decision followed in January 2012.
Yes. FDA's Health Fraud Product Database lists 24 entries, dated 2013 to 2019, for consumer products containing undeclared dapoxetine, each alongside another undeclared drug such as sildenafil, tadalafil or desmethyl carbodenafil (checked October 22, 2026).
Dapoxetine Hydrochloride's CAS Registry Number is 129938-20-1. It is also sold as Dapoxetine HCl, Dapoxetine Hydrochloride, Priligy.
