Bremelanotide Rx

T-03

PT-141 study-dose explorer

Every dose any bremelanotide (or precursor Melanotan-II) trial actually tested, sortable by population, route, dose and year, with outcome, grade and integrity flags. Exists so any quoted 'PT-141 dose' can be checked against what was actually studied.

Every dose you see quoted for PT-141 traces to one of a small number of studies, and the studies disagree with the marketing more than with each other: the approved regimen is a fixed 1.75 mg autoinjector for premenopausal women; the male data are single-dose proof-of-concept studies from 2004 to 2008, two of them now integrity-flagged; and plasma exposure plateaus at 7.5 mg, above which more drug mostly means more nausea window. This table puts every studied dose in one place so a quoted number can be checked against what was actually tested.

Published records (13 of 13)

Study contextSpeciesDose as publishedRoute
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedhumannot statednot stated
not statedratnot statednot stated

Every row restates a published record; sources resolve on the sourced monograph. Species is part of the data: this table never scales an animal dose into a human figure.

Worked example

How to read a claim against this table: a vendor quoting 'PT-141 2 mg for men' is quoting no study at all. The male subcutaneous data are 0.3 to 10 mg single doses (significant above 1 mg in healthy men; 4 to 6 mg in sildenafil non-responders), the male intranasal data are 4 to 20 mg (significant above 7 mg), and the only approved dose in anyone is 1.75 mg SC in premenopausal women with HSDD. No male regimen of any kind was ever approved; FDA's review says those programs did not lead to approved products.

Step by step

  1. Find the population that matches the claim you are checking: premenopausal women with HSDD (approved), men with ED (former program), obese women (phase 1 mechanism), or rats.
  2. Read the dose, route and duration columns together: single-dose lab studies say nothing about monthly use.
  3. Check the outcome column for what was actually measured, and whether the row carries an integrity flag.
  4. Compare against the label limits in T-01: any regimen beyond 1 dose/24 h or 8/month is outside every human study's protocol except the short daily-dosing safety studies that produced 38% skin darkening.

Tools: educational calculators and references only.

Email me the evidence brief