1. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Palatin Technologies, Inc723 participantsDec 2014 to 30 Jun 2017
Hypoactive Sexual Desire Disorder
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated
Comparing 2 peptides · Data version 308560
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| Peptide | Synthetic analog Bremelanotide (PT-141) | Synthetic analog Melanotan I (afamelanotide) | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Synthetic analog | |
| Area | Sexual health and hormones | Sexual health and hormones | |
| Evidence | |||
| Amount of evidence | 128 | 667 | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 42 (40 in people) | 36 (29 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 10 · 1 active | 23 · 1 active | |
Shared outcomes
From the regulatory data of each peptide.
The FDA label for Vyleesi says: “Premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) with low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, relationship problems, or a medication or drug” No central EU authorisation (EMA).
Outcome groups with study results for at least two of these peptides. Counts include only results from studies that gave the peptide. Bar length is the number of results, on one scale. The bars show how much was studied, not how large an effect was. A peptide with more studies can look stronger here without being stronger. For results, see the randomized results above.
| Outcome group | Bremelanotide (PT-141) | Melanotan I (afamelanotide) |
|---|---|---|
| Receptor activity and mechanismNervous system and cognition | 10532 |
PepBank is a research reference. Talk to a doctor before you use any peptide.
The EMA label for Scenesse says: “Prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP)”
| Adverse eventsWhole body | 2929 | 29245 |
|---|
| PigmentationSkin and wound | 22 | 4324316 |
|---|
| PharmacokineticsPharmacology | 1082 | 10631 |
|---|
| Appetite and food intakeMetabolic and weight | 22 | 2525 |
|---|
| Blood pressureCardiovascular | 55 | 33 |
|---|
| Sex hormones and fertilityEndocrine and hormones | 44 | 725 |
|---|
| Exercise and physical functionNervous system and cognition | 11 | 651 |
|---|
| Treatment adherence and retentionWhole body | 11 | 44 |
|---|
| Body weightMetabolic and weight | 22 | 33 |
|---|
| Heart functionCardiovascular | 11 | 66 |
|---|
| MortalityWhole body | 11 | 11 |
|---|
Each analog against its native parent, residue by residue. Substitutions, non-standard residues and modifications are marked. Calculated from the two sequences.
Bremelanotide (PT-141) differs from Alpha-melanocyte-stimulating hormone (alpha-MSH) at 4 positions.
What is different
Melanotan I (afamelanotide) differs from Alpha-melanocyte-stimulating hormone (alpha-MSH) at 2 positions and carries 2 added groups.
What is different
For each outcome that two or more peptides have results for: the best result of a single randomized trial, on the same measure (the same kind of number, the same unit). When a trial has several dose arms, the cell shows the highest dose arm. The trials differ in people, length and dose, so a gap between two cells is not proof that one peptide works better.
No outcome has a randomized-trial result on the same measure for two or more of these peptides yet.
The other peptides have no randomized result on the same measure, so these results cannot be set side by side.
| Outcome | Bremelanotide (PT-141) | Melanotan I (afamelanotide) |
|---|---|---|
| PharmacokineticsPharmacologyCompared as: value in the arm that got the peptide, in h | 0.5 h Tmax (median) · intranasal PT-141 n not reported2004 | No comparable result 6 randomized-trial results measure it in another way or another unit. |
| Appetite and food intakeMetabolic and weightCompared as: difference from placebo, in kcal | 398 to 469 kcal Mean difference in caloric intake 4-day treatment periodsn not reported2022 | No randomized trial result 25 results from other study designs. |
| Body weightMetabolic and weightCompared as: value in the arm that got the peptide, in kg | −1.7 kg Mean body weight reduction · Shown as a change. The study reports a mean body weight reduction of this size. Placebo: −0.9 kg 4-day treatment periodsn not reported2022 | |
| Treatment adherence and retentionWhole bodyCompared as: value in the arm that got the peptide, in % | 70% Proceeded to open-label Placebo: 87% n not reported2022 | No randomized trial result 4 results from other study designs. |
| Adverse eventsWhole bodyCompared as: share of people in the arm that got the peptide, in % | ≥ 10% Nausea incidence Dose studied: 1.75 mg24 weeksn = 1,2472019 | No comparable result 7 randomized-trial results measure it in another way or another unit. |
0.5 h
Tmax (median) · intranasal PT-141
n not reported2004
No comparable result
6 randomized-trial results measure it in another way or another unit.
No randomized trial result
3 results from other study designs.
398 to 469 kcal
Mean difference in caloric intake
4-day treatment periodsn not reported2022
No randomized trial result
25 results from other study designs.
−1.7 kg
Mean body weight reduction · Shown as a change. The study reports a mean body weight reduction of this size.
Placebo: −0.9 kg
4-day treatment periodsn not reported2022
No randomized trial result
3 results from other study designs.
70%
Proceeded to open-label
Placebo: 87%
n not reported2022
No randomized trial result
4 results from other study designs.
≥ 10%
Nausea incidence
Dose studied: 1.75 mg24 weeksn = 1,2472019
No comparable result
7 randomized-trial results measure it in another way or another unit.
Registered trials, ranked by phase (late phases first), then posted results and enrollment. Status is the registry status. Study results come from published studies. Results posted at ClinicalTrials.gov are shown on each trial page.
Top 3 of 10 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Palatin Technologies, Inc723 participantsDec 2014 to 30 Jun 2017
Hypoactive Sexual Desire Disorder
Palatin Technologies, Inc714 participantsJan 2015 to 29 Jun 2017
Hypoactive Sexual Desire Disorder
Imperial College Healthcare NHS Trust40 participants7 Oct 2019 to 6 Oct 2020
Hypoactive Sexual Desire Disorder
Top 3 of 23 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
Clinuvel Pharmaceuticals Limited100 participantsMay 2007 to 9 Dec 2009
Erythropoietic Protoporphyria
Clinuvel Pharmaceuticals Limited93 participantsMay 2012 to Jul 2013
Erythropoietic Protoporphyria
Clinuvel Pharmaceuticals Limited74 participantsSept 2009 to May 2011
Erythropoietic Protoporphyria