PT-141 Nasal Spray: What Studies Show
Which studies gave PT-141 as a nasal spray form, what they measured, and what is approved. No product recommendations.
- Route
- nasal spray
- FDA-approved product for this route
- None
- Route studies (human / animal)
- 4 / 0
- in our evidence file (PubMed search, 2 Oct 2026)
Studies that gave PT-141 nasal spray
Each row is a study whose stated route matches. Animal and cell results are labelled and are not human results.
| Study | Design | n | Dose | First outcome |
|---|---|---|---|---|
| Clinical therapeutics 2017, PMID 28189361 | Human RCT | 24 | 20 mg | Not stated |
| The Journal of urology 2008, PMID 18206919 | Human RCT | 342 | 10 mg | Positive clinical response in sildenafil non-responders: 51 (33.5%) of the bremelanotide group had positive clinical results versus 13 (8.5%) on placebo (p = 0.03). |
| The journal of sexual medicine 2006, PMID 16839319 | Human RCT | 18 | 20 mg | Sexual desire: More women reported moderate or high desire after bremelanotide than placebo (P = 0.0114). |
| International journal of impotence research 2004, PMID 14963471 | Human RCT | Not stated | Not stated | Erectile response (RigiScan): Erectile response beat placebo at doses above 7 mg; first erection began in about 30 minutes. |
For the injected form, see PT-141 how to inject and PT-141 half-life.
The nasal study in women
The one intranasal study in women gave a single dose of 20 mg or placebo in a crossover design to eighteen premenopausal women with female sexual arousal disorder, in clinic sessions.[3]
More of those women reported moderate or high desire after the active nasal dose than after placebo.[3]
The nasal studies in men
In the largest nasal trial, 342 married men with erectile dysfunction that had not responded to sildenafil were randomized to a 10 mg nasal spray or placebo before sexual stimulation.[2]
A placebo-controlled nasal study in healthy men and men with mild-to-moderate erectile dysfunction found a response above placebo at doses greater than 7 mg, with first erections around 30 minutes.[4]
How nasal absorption looks next to injection
In healthy men given the nasal form, exposure rose with dose, the median peak came at 0.50 h and the mean half-life ran from 1.85 to 2.09 hours.[4]
A phase I study states its 20 mg nasal dose gave an exposure about 1 to 2 times that of the subcutaneous dose then in phase III.[1]
Safety seen with the nasal route
Flushing and nausea were the most common adverse events in the two nasal studies in men, and no maximum-tolerated dose was found.[4]
In 24 healthy participants, single 20 mg nasal doses with or without alcohol were found to be safe and generally well tolerated.[1]
Which route is approved
The only approved bremelanotide product is a subcutaneous autoinjector, so no nasal spray carries an FDA label.[5]
Common questions
Is there an FDA-approved nasal spray form of PT-141?
We found no FDA-approved nasal spray product for PT-141 in our evidence file. Products sold as nasal spray forms are not checked by the FDA.
Have studies given PT-141 as a nasal spray form?
4 studies in our evidence file gave PT-141 by a nasal spray route: 4 in people and 0 in animals.
Is there an approved PT-141 nasal spray?
No: the label for the approved product describes it for subcutaneous administration via an autoinjector.[5]
How well does PT-141 nasal spray work compared with injection?
No trial compared the two routes head to head; the only link is a phase I statement of approximate exposure.[1]
More on PT-141
Sources
- 1Phase I Randomized Placebo-controlled, Double-blind Study of the Safety and Tolerability of Bremelanotide Coadministered With Ethanol in Healthy Male and Female Participants.Clinical therapeutics · 2017PMID 28189361Accessed 2 Oct 2026
- 2Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study.The Journal of urology · 2008PMID 18206919Accessed 2 Oct 2026
- 3An effect on the subjective sexual response in premenopausal women with sexual arousal disorder by bremelanotide (PT-141), a melanocortin receptor agonist.The journal of sexual medicine · 2006PMID 16839319Accessed 2 Oct 2026
- 4Double-blind, placebo-controlled evaluation of the safety, pharmacokinetic properties and pharmacodynamic effects of intranasal PT-141, a melanocortin receptor agonist, in healthy males and patients with mild-to-moderate erectile dysfunction.International journal of impotence research · 2004PMID 14963471Accessed 2 Oct 2026
- 5VYLEESI prescribing information (FDA label)FDA label, DailyMed · current labeldailymed.nlm.nih.govAccessed 2 Oct 2026
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