Sexual HealthFDA Approved

PT-141

Bremelanotide

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Reconstitution

Overview

PT-141 (Bremelanotide) is a cyclic heptapeptide melanocortin receptor agonist derived from Melanotan II. It is FDA-approved as Vyleesi (2019) for hypoactive sexual desire disorder in premenopausal women only.

Mechanism of Action

Non-selective melanocortin receptor agonist (MC1R > MC4R > MC3R > MC5R > MC2R per FDA label). Sexual response is driven by central MC4R activation in the medial preoptic area and paraventricular nucleus of the hypothalamus, modulating dopaminergic and oxytocinergic arousal pathways independently of PDE5/vascular mechanisms.

Research Summary

FDA-approved in June 2019 under the brand name Vyleesi (NDA 210557) for premenopausal women with acquired, generalized HSDD, based on the two Phase III RECONNECT trials (Kingsberg/Simon et al., Obstet Gynecol 2019). Earlier Phase II work in men with erectile dysfunction (intranasal and SubQ bremelanotide, including Safarinejad 2008 sildenafil-salvage study) showed modest efficacy but was not pursued to approval. Use in men is off-label and largely grey-market.

Dosing Information

Typical Dose

1.75mg

Range

1.75mg (FDA-approved Vyleesi dose)

Frequency

As needed, subcutaneous (max once/24h, max 8 doses/month)

Route

SubQ

Duration

As needed; discontinue if no benefit after 8 weeks

Reconstitution

10mg vial + 2mL bacteriostatic water = 5,000mcg/mL (0.35mL draw for 1.75mg dose)

Notes

FDA-approved dose is 1.75 mg SubQ (abdomen or thigh) via autoinjector. No more than one dose per 24 hours and no more than 8 doses per month. Discontinue if no benefit after 8 weeks. Patients should be screened for cardiovascular disease and have blood pressure controlled before use; alcohol should be avoided around dosing. Not a chronic therapy.

Verified testing for PT-141

Aggregated from 75 lab-verified Certificates of Analysis uploaded directly by 1 verified lab. Purity averages exclude values outside [50%, 100%] to filter unit-misreads.

COAs

Verified labs

Avg purity

99.74%

±0.26%

Endotoxin tested

44%

Tested by

ILS Labs4 COAsA

See every PT-141 COA

Reported Side Effects

Nausea (most common, ~40%; often dose-limiting)
Flushing
Headache
Injection site reactions
Transient blood pressure increase (~6 mmHg SBP) with reflex decrease in heart rate
Focal hyperpigmentation (face, gums, breasts) with repeated dosing

Contraindications

Uncontrolled hypertension
Known cardiovascular disease
Pregnancy (potential fetal harm per animal studies)
Concurrent use with oral naltrexone (may reduce naltrexone efficacy for alcohol/opioid use disorder)

Labs to monitor before & during your PT-141 protocol

These biomarkers are commonly tracked to assess response and safety. Run baseline labs before starting, mid-cycle labs halfway through, and post-cycle labs 1–2 weeks after the final dose.

Blood pressureHeart rateTestosteroneSHBGEstradiol

Research References

Kingsberg SA, Clayton AH, Portman D, Williams LA, Krop J, Jordan R, Lucas J, Simon JA. Bremelanotide for the Treatment of Hypoactive Sexual Desire Disorder: Two Randomized Phase 3 Trials. Obstet Gynecol. 2019;134(5):899-908. PMID: 31599840.
Dhillon S, Keam SJ. Bremelanotide: First Approval. Drugs. 2019;79(14):1599-1606. PMID: 31429064.
VYLEESI (bremelanotide injection) FDA Prescribing Information, NDA 210557, 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf

This platform provides informational tools only, not medical advice. This information is for educational purposes only. Consult a licensed provider.