Dose record · Label & research context

PT-141 dosage: what the label specifies and what the studies used

The approved dose as documented, the ranges studied across programs, and the pharmacokinetics — reported as a record, never as a recommendation.

The short version

This page reports PT-141 dosage as it appears in the approved label and the published studies. It does not recommend a dose for anyone. There is an important distinction up front: the approved drug has one labeled dose, while the research literature used a range of doses across different programs and routes.

For the approved use, the US prescribing information specifies 1.75 mg injected under the skin, as needed, with a hard ceiling of one dose per 24 hours and no more than eight doses per month [7]. Early erectile-dysfunction research used much higher intranasal doses; obesity research used a different schedule entirely [10]. The drug acts fast — within an hour — and clears within a few hours [7]. None of these figures is guidance; they are the record.

PT-141 dosage: the approved label figures

The label-attested dose, for the approved HSDD indication in premenopausal women, is 1.75 mg subcutaneous, as needed, taken at least 45 minutes before anticipated sexual activity, with no more than one dose in 24 hours and no more than eight doses per month [7]. This is the only dose the FDA approved, and it is tied to that one indication.

The label is precise on disposition: median Tmax is about 0.5-1.0 hour, terminal half-life about 2.7 hours (range 1.9-4.0 h), volume of distribution about 25.0 L, and clearance about 6.5 L/hr [7]. It also carries a warning on transient blood-pressure increase and contraindicates use in uncontrolled hypertension or cardiovascular disease [7]. These are documented label facts, reported here as a record — not a dosing instruction for any person.

PT-141 dosage for women

PT-141 dosage for women, in the approved context, is the 1.75 mg subcutaneous as-needed dose described above — that is the dose studied in the RECONNECT Phase 3 trials and carried into the label [3][7]. The Phase 2 dose-finding work in women evaluated 0.75, 1.25, and 1.75 mg subcutaneously before the 1.75 mg dose was selected.

A separate Phase 1 research line studied subcutaneous doses up to 2.5 mg, up to three times daily for 15 days, in a metabolic (caloric-intake) context — a research protocol only, not an approved or sexual-function use. The female-rat preclinical work that established the desire mechanism used subcutaneous dose-ranging that does not translate to a human figure [2]. Again: described, not recommended.

Doses studied outside the approved use

Outside the approved indication, the studied doses look very different. Early intranasal research in men with erectile dysfunction escalated to roughly 7-20 mg, with a statistically significant erectile response above about 7 mg [10]. That intranasal program was later discontinued for pharmacokinetic variability, and the drug moved to the subcutaneous route [10].

These higher historical doses are part of the development record, not a current protocol, and they were not the basis for the approval. They are included so the dose picture is complete and honest: the approved 1.75 mg subcutaneous figure is far lower than the early intranasal exploratory doses, and the routes differ. No figure on this page is a recommendation.

Routes, stability, and why no dose is recommended here

Three routes appear in the literature: subcutaneous (the approved route), intranasal (early development, discontinued), and intravenous (early pharmacology) [7][10]. The cyclic lactam structure makes the molecule more stable than linear melanocortin peptides, which is part of why a subcutaneous as-needed product was feasible [7].

This site is editorial. It reports the approved label dose and the studied ranges as a documented record. It does not tell any individual what to take, how to reconstitute material, or how to dose — those are clinical decisions outside the scope of a research digest. Material sold as research-grade "PT-141" has no verified concentration, which makes any dose figure meaningless for that product anyway.