Multicentre Phase III Erythropoietic Protoporphyria Study
Clinuvel Pharmaceuticals Limited100 participantsMay 2007 to 9 Dec 2009
Erythropoietic Protoporphyria
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
Swipe sideways to see every peptide.
| Peptide | Synthetic analog Melanotan I (afamelanotide) | Natural peptide Oxytocin | |
|---|---|---|---|
| Identity | |||
| Kind | Synthetic analog | Natural peptide | |
| Area | Sexual health and hormones | Sexual health and hormones | |
| Evidence | |||
| Amount of evidence | 667 | 3,492 (plus 1,148 on natural levels, listed separately) | |
| Evidence level | Has results from studies in people | Has results from studies in people | |
| Safety | |||
| Safety results | 36 (29 in people) | 157 (152 in people) | |
| Status | |||
| Approval | |||
| Sport (WADA) | |||
| Registered trials | 23 · 1 active | 690 · 65 active238 more mention it but do not test it | |
Shared outcomes
From the regulatory data of each peptide.
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 | Melanotan I (afamelanotide) | Oxytocin |
|---|---|---|
| Cognition and memoryNervous system and cognition | 33 | 41440311 |
| Anxiety and moodMental health and mood |
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)”
The FDA label for Pitocin says: “Antepartum: medically indicated induction of labor, stimulation or reinforcement of labor, adjunctive therapy in incomplete or inevitable abortion” No central EU authorisation (EMA).
99
34132417 |
| Receptor activity and mechanismSkin and wound | 231521781 | 28960801472 |
|---|
| Adverse eventsWhole body | 29245 | 1261233 |
|---|
| PainSkin and wound | 752 | 1098524 |
|---|
| PharmacokineticsPharmacology | 10631 | 9168203 |
|---|
| Appetite and food intakeNervous system and cognition | 2525 | 946727 |
|---|
| Addiction, withdrawal and alcohol intakeNervous system and cognition | 22 | 67643 |
|---|
| Stress hormonesEndocrine and hormones | 22 | 7560123 |
|---|
| Sex hormones and fertilityReproductive and sexual health | 725 | 150328632 |
|---|
| Heart functionCardiovascular | 66 | 76353110 |
|---|
| Inflammation markersRespiratory | 534310 | 3210166 |
|---|
Each analog against its native parent, residue by residue. Substitutions, non-standard residues and modifications are marked. Calculated from the two sequences.
Melanotan I (afamelanotide) differs from Alpha-melanocyte-stimulating hormone (alpha-MSH) at 2 positions and carries 2 added groups.
What is different
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 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
Top 3 of 690 trials, ranked by phase, then posted results and enrollment: 3 completed · 3 with posted results · source ClinicalTrials.gov (opens in a new tab)
University of Alabama at Birmingham1,798 participantsNov 2008 to Jun 2010
Uterine Atony · Postpartum Hemorrhage
Northwestern University1,003 participants28 Sept 2015 to 28 Sept 2020
Dystocia
University of Zimbabwe506 participants8 Apr 2018 to 30 Jun 2019
Post Partum Hemorrhage
238 more mention it but do not test it. They only measure it or name it in their text.
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 | Melanotan I (afamelanotide) | Oxytocin |
|---|---|---|
| PharmacokineticsPharmacologyCompared as: value in the arm that got the peptide, in effect size | No comparable result 6 randomized-trial results measure it in another way or another unit. | −1.12 effect size Effect size Dose studied: 48 IU/day6 weeksn = 1032020 |
| Appetite and food intakeMetabolic and weightCompared as: difference from placebo, in kcal | No randomized trial result 25 results from other study designs. | −152 kcal Difference in caloric intake Dose studied: 24 IU four times daily8 weeksn = 612024 |
| Body weightMetabolic and weightCompared as: difference from placebo, in g | No randomized trial result 3 results from other study designs. | 196 g Difference in total fat Dose studied: 24 IU four times daily8 weeksn = 612024 |
| Liver fat and liver functionLiverCompared as: difference from placebo, in proportion | No randomized trial result 5 results from other study designs. | −0.01 proportion Difference in liver fat fraction Dose studied: 24 IU four times daily8 weeksn = 612024 |
| Sex hormones and fertilityEndocrine and hormonesCompared as: value in the arm that got the peptide, in % | No randomized trial result 7 results from other study designs. | 14.4% Mean percent change testosterone Dose studied: 24 IUn = 452020 |
| Addiction, withdrawal and alcohol intakeMental health and moodCompared as: value in the arm that got the peptide, in mg | No randomized trial result 2 results from other study designs. | 56.8 mg Mean total oxazepam dose Placebo: 79 mg Dose studied: 24 IU twice dailythree daysn = 402019 |
| Anxiety and moodReproductive and sexual healthCompared as: value in the arm that got the peptide, in % | No randomized trial result 9 results from other study designs. | −20% Score reduction · Shown as a change. The study reports a score reduction of this size. Placebo: −4% Dose studied: 20 IU twice daily in week 1, then 40 IU twice daily8 weeksn = 402013 |
| Cognition and memoryNervous system and cognitionCompared as: difference from placebo, in sd | No randomized trial result 3 results from other study designs. | 1.39 SD effect size n = 262017 |
| Glycemic controlMetabolic and weightCompared as: value in the arm that got the peptide, in mmol/l × min | No randomized trial result 1 result from other study designs. | 2240 mmol/L × min Glucose AUC Placebo: 2190 mmol/L × min Dose studied: 24 IUn = 252024 |
| Exercise and physical functionNervous system and cognitionCompared as: difference from placebo, in kg | No randomized trial result 6 results from other study designs. | 2.25 kg Whole body lean mass difference Dose studied: 24 IU 4 times per day8 weeksn = 212021 |
| LipidsCardiovascularCompared as: difference from placebo, in mg/dl | No randomized trial result 1 result from other study designs. | −19.3 mg/dL LDL cholesterol change Dose studied: 24 IU 4 times per day8 weeksn = 212021 |
| Receptor activity and mechanismNervous system and cognitionCompared as: value in the arm that got the peptide, in proteins | No randomized trial result 231 results from other study designs. | 198 proteins Differentially expressed proteins Dose studied: 24 IUsingle dosen = 192026 |
No comparable result
6 randomized-trial results measure it in another way or another unit.
−1.12 effect size
Effect size
Dose studied: 48 IU/day6 weeksn = 1032020
No randomized trial result
25 results from other study designs.
−152 kcal
Difference in caloric intake
Dose studied: 24 IU four times daily8 weeksn = 612024
No randomized trial result
3 results from other study designs.
196 g
Difference in total fat
Dose studied: 24 IU four times daily8 weeksn = 612024
No randomized trial result
5 results from other study designs.
−0.01 proportion
Difference in liver fat fraction
Dose studied: 24 IU four times daily8 weeksn = 612024
No randomized trial result
7 results from other study designs.
14.4%
Mean percent change testosterone
Dose studied: 24 IUn = 452020
No randomized trial result
2 results from other study designs.
56.8 mg
Mean total oxazepam dose
Placebo: 79 mg
Dose studied: 24 IU twice dailythree daysn = 402019
No randomized trial result
9 results from other study designs.
−20%
Score reduction · Shown as a change. The study reports a score reduction of this size.
Placebo: −4%
Dose studied: 20 IU twice daily in week 1, then 40 IU twice daily8 weeksn = 402013
No randomized trial result
3 results from other study designs.
1.39 SD
effect size
n = 262017
No randomized trial result
1 result from other study designs.
2240 mmol/L × min
Glucose AUC
Placebo: 2190 mmol/L × min
Dose studied: 24 IUn = 252024
No randomized trial result
6 results from other study designs.
2.25 kg
Whole body lean mass difference
Dose studied: 24 IU 4 times per day8 weeksn = 212021
No randomized trial result
1 result from other study designs.
−19.3 mg/dL
LDL cholesterol change
Dose studied: 24 IU 4 times per day8 weeksn = 212021
No randomized trial result
231 results from other study designs.
198 proteins
Differentially expressed proteins
Dose studied: 24 IUsingle dosen = 192026