FDA Drug Label
VYLEESI (bremelanotide injection) for subcutaneous use - Prescribing Information
AMAG, 2019
Sexual HealthFDA ApprovedS
PT-141
Bremelanotide / Vyleesi
PT-141 (bremelanotide, brand: Vyleesi) is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike PDE5 inhibitors, PT-141 acts centrally on melanocortin receptors in the CNS to increase sexual desire and arousal rather than acting peripherally on blood flow. Administered as a subcutaneous autoinjector 45 minutes before anticipated sexual activity. Banned from 503A compounding pharmacies.
Observational report only — live community data. Not medical advice. Does not recommend doses, protocols, or treatments.
- Studies cited
- 7
- Research grade
- S
- Experience
- 14
- Activity
- 63
Overall check-ins
Trackers & reports
Overview
About PT-141
PT-141 (bremelanotide, brand: Vyleesi) is FDA-approved for hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike PDE5 inhibitors, PT-141 acts centrally on melanocortin receptors in the CNS to increase sexual desire and arousal rather than acting peripherally on blood flow. Administered as a subcutaneous autoinjector 45 minutes before anticipated sexual activity. Banned from 503A compounding pharmacies.
- Category
- Sexual Health
- Regulatory status
- FDA Approved
- Also known as
- Bremelanotide / Vyleesi
- Self-reports
- 27
Community
What 27 users report
27 community reports
Overall experience
From check-in ratings — separate from side effects logged below. Side effects are logged separately from overall experience. A favorable check-in can still include nausea, fatigue, or injection-site reactions.
Favorable 3% · Mixed 2% · Unfavorable overall 95%
Most reported benefits
Benefits users selected when logging a favorable or mixed check-in.
Libido
113
Most logged side effects
Side effects are logged separately from overall experience. A favorable check-in can still include nausea, fatigue, or injection-site reactions.
Nausea
38
Headache
37
Injection site irritation
35
Self-reported dose per injection
Median bucket: 2–3 mg · Most common: 2–3 mg
Reports span 0.1–3 mg
0.1–0.2 mg
1
0.2–0.4 mg
2
0.4–0.6 mg
9
0.6–1 mg
3
1–2 mg
8
2–3 mg
90
Anonymized self-reports from PeptIQ users — not prescribing guidance. Buckets group similar logged amounts; open-ended top buckets mean “at least” that dose.
Commonly stacked with
How repeat users are trending
Among repeat reporters, 87% said they felt similar to their last entry, 13% more positive, and 0% more negative.
Overall, repeat reporters leaned more positive than their previous entry.
Median gap between entries: 100 days · Based on 23 repeat reporters
Research
Cited research (5)
Source
PubMed
Bremelanotide: New Drug for Treating Hypoactive Sexual Desire Disorder
Kingsberg et al., 2019
ClinicalTrials.gov
Bremelanotide (PT-141) studies on ClinicalTrials.gov
ClinicalTrials.gov, 2024
PubMed
Hypoactive Sexual Desire Disorder in Women: Physiology, Assessment, Diagnosis, and Treatment
Pettigrew et al., 2021
PubMed
Pharmacologic therapeutic options for sexual dysfunction
Burton et al., 2022
Tools
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More ways to learn about PT-141 from observational PeptIQ data.
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Frequently asked
What do PeptIQ users report about PT-141?
This page summarizes 27 anonymized self-reports from PeptIQ users who track PT-141, including commonly reported effects and co-tracked peptides. These are observational patterns, not clinical outcomes.
How do side effects relate to overall experience for PT-141?
PeptIQ separates overall check-in ratings (favorable, mixed, or unfavorable) from logged side effects like nausea or fatigue. Users often report benefits and side effects in the same check-in — a high experience score does not mean zero side effects were noted.
What research is cited for PT-141?
5 sources are linked on this page, including PubMed articles, clinical trial registries, and FDA labels where applicable. Citations describe published research — not recommendations.
Is PT-141 safe to use?
This wiki does not assess safety or recommend use. PT-141 is listed as FDA Approved. Consult a licensed clinician for personal medical decisions.
What are the purported benefits and uses of PT-141?
Research, primarily in animal models, suggests PT-141 may have a wide range of therapeutic potentials due to its ability to promote angiogenesis (formation of new blood vessels), stimulate collagen synthesis, and modulate inflammatory responses.
SourceWhat is the legal status of PT-141?
PT-141 is not approved by the FDA for any human use. There is no legal basis for selling it as a drug, food, or dietary supplement in the United States. The FDA has classified PT-141 as a Category 2 bulk drug substance, which explicitly prohibits licensed compounding pharmacies from using it in compounded medications.
SourceWhat are the known or theoretical side effects and risks of PT-141?
The safety and effectiveness of PT-141 have not been thoroughly evaluated in humans through rigorous clinical trials. This lack of human data means that safe dosages, short-term side effects, and long-term health consequences are largely unknown.
SourceWhat is the current state of research on PT-141?
While there are over 200 published studies on PT-141, the vast majority are animal or in vitro (cell) studies. These preclinical studies consistently show positive results across various tissue types. However, there is a significant lack of comprehensive human clinical trial data.
Source