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PT-141

PT-141 · Bremelanotide · Vyleesi · PT141

B
Limited human data
RouteInjectableFDA-approved
B
Evidence grade: Limited human data

Pilot studies, observational data, or smaller RCTs. Grades summarize evidence quality, not whether a compound is appropriate, legal, or risk-free.

At a glance
What it is
Synthetic cyclic heptapeptide melanocortin receptor agonist; FDA-approved as bremelanotide for acquired generalized HSDD in premenopausal women.
Why people use it
Female HSDD · Male Erectile Dysfunction · Psychogenic ED Specifically · Female Sexual Arousal Disorder Beyond HSDD · Blood Pressure and Cardiovascular Effects
What the evidence supports
Women (HSDD): Two Phase 3 RCTs (RECONNECT studies), n=1,247 premenopausal women; statistically significant improvement in desire and reduced distress vs placebo. Grade A. Men (ED): Phase 2 data — 34% vs 9% placebo response in PDE5 non-responders; Phase 3 not completed for male indication. Grade B.
Key risks
Key risks: ABSOLUTE CONTRAINDICATION: UNCONTROLLED HYPERTENSION AND CARDIOVASCULAR DISEASE Bremelanotide transiently increases blood pressure after every dose. This is mechanistically inherent — it cannot be avoided by dose reduction or route modification. The FDA label states: do not use Vyleesi in patients with uncontrolled high blood pressure or known cardiovascular disease. These are not precautions. They are absolute contraindications. For anyone with hypertension requiring medication: blood pressure must be well-controlled before PT-141 is considered, and should be discussed with the prescribing physician. For anyone with known cardiovascular disease (coronary artery disease, prior MI, stroke, heart failure, peripheral vascular disease): do not use. For anyone who has not had blood pressure measured recently: check blood pressure before the first dose. A single unrecognized hypertensive episode from PT-141 use in a cardiovascular patient could be life-threatening. This is the most serious safety concern associated with this compound..
If you only read one thing

The central tension resolved: PT-141 exists in two parallel realities. As Vyleesi, it is an FDA-approved pharmaceutical for premenopausal women with HSDD, backed by two Phase 3 RCTs with 1,247 participants, a defined safety profile with documented contraindications, and physician-supervised access.

Route / form

Same compound, route-specific context. Switch forms instead of opening separate pages.

Evidence fit
Route-specific

Use the route notes below to match form, goal, and evidence quality.

Route caveat
Screen contraindications

Hard-stop risk to review first: ABSOLUTE CONTRAINDICATION: UNCONTROLLED HYPERTENSION AND CARDIOVASCULAR DISEASE Bremelanotide transiently increases blood pressure after…

Protocol anchor
Full dosing section

Open the full report at the dosing chapter for protocol rows, cycle context, and administration notes.

Typical dose snapshot
See route notes
Evidence varies by use case
Published literature
4human RCTs1human study0animal0in vitro
Evidence reality check
Human evidence
5 human studies
4 randomized; 1 observational.
Preclinical base
0 lab signals
0 animal; 0 in-vitro/mechanistic.
Evidence snapshot
Women (HSDD): Two Phase 3 RCTs (RECONNECT studies), n=1,247 premenopausal women; statistically significant improvement in desire and reduced distress vs placebo. Grade A. Men (ED): Phase 2 data — 34% vs 9% placebo response in PDE5 non-responders; Phase 3 not completed for male indication. Grade B.
From the chapter quick-reference block.
Indication map
Supported / plausible / speculative / avoid
Plausible
Female HSDD · Male Erectile Dysfunction · Psychogenic ED Specifically · Female Sexual Arousal Disorder Beyond HSDD · Blood Pressure and Cardiovascular Effects
Women (HSDD): Two Phase 3 RCTs (RECONNECT studies), n=1,247 premenopausal women; statistically significant improvement in desire and reduced distress vs placebo. Grade A. Men (ED): Phase 2 data — 34% vs 9% placebo response in PDE5 non-responders; Phase 3 not completed for male indication. Grade B.
Avoid
ABSOLUTE CONTRAINDICATION: UNCONTROLLED HYPERTENSION AND CARDIOVASCULAR DISEASE Bremelanotide transiently increases blood pressure after every dose. This is mechanistically inherent — it cannot be avoided by dose reduction or route modification. The FDA label states: do not use Vyleesi in patients with uncontrolled high blood pressure or known cardiovascular disease. These are not precautions. They are absolute contraindications. For anyone with hypertension requiring medication: blood pressure must be well-controlled before PT-141 is considered, and should be discussed with the prescribing physician. For anyone with known cardiovascular disease (coronary artery disease, prior MI, stroke, heart failure, peripheral vascular disease): do not use. For anyone who has not had blood pressure measured recently: check blood pressure before the first dose. A single unrecognized hypertensive episode from PT-141 use in a cardiovascular patient could be life-threatening. This is the most serious safety concern associated with this compound.
See section 8.4.

PT-141 / bremelanotide is the most rigorously evidenced compound in this reference and also the one whose community use deviates most completely from the evidence base. The FDA approved it for women. The community uses it primarily for men. The evidence quality for the approved indication is exceptional. The evidence quality for the primary community use is solid but incomplete.

The central tension resolved: PT-141 exists in two parallel realities. As Vyleesi, it is an FDA-approved pharmaceutical for premenopausal women with HSDD, backed by two Phase 3 RCTs with 1,247 participants, a defined safety profile with documented contraindications, and physician-supervised access. As PT-141, it is a research chemical used primarily by men for erectile dysfunction and libido enhancement, off-label from the approved indication, with Phase 2 evidence showing 34% response in PDE5 non-responders, and community consensus reporting consistent efficacy at 1-2 mg SubQ doses. These are the same molecule. They are not the same evidence context, the same user, the same indication, or the same level of regulatory oversight.

The strongest argument for PT-141: it is the only compound in this reference with a mechanistic reason to believe it provides something that nothing else does. PDE5 inhibitors improve blood flow. PT-141 creates the desire and arousal that blood flow alone cannot produce. For men with psychogenic ED, low libido, or PDE5 inhibitor treatment failure, the central MC4R mechanism addresses the deficit that peripheral vascular agents cannot touch. The Phase 2 data shows 34% response in the hardest-to-treat population. The mechanism is independently confirmed. The safety profile in the Phase 3 data is well-characterized, which makes the contraindications clear rather than uncertain.

The strongest argument for caution: the blood pressure increase is mechanistically inherent and cannot be avoided. For anyone with cardiovascular disease or uncontrolled hypertension, PT-141 is an absolute contraindication — not a question of careful dosing, a question of not using it at all. The hyperpigmentation risk at 1% may sound small but is potentially permanent in half of affected individuals. The community's use pattern (men, off-label, research chemical, variable doses) operates outside the safety monitoring infrastructure that the FDA approval was built on.

Properties
✓ FDA-approved✓ Human RCTNot injectable
  • ABSOLUTE CONTRAINDICATION: UNCONTROLLED HYPERTENSION AND CARDIOVASCULAR DISEASE Bremelanotide transiently increases blood pressure after every dose. This is mechanistically inherent — it cannot be avoided by dose reduction or route modification. The FDA label states: do not use Vyleesi in patients with uncontrolled high blood pressure or known cardiovascular disease. These are not precautions. They are absolute contraindications. For anyone with hypertension requiring medication: blood pressure must be well-controlled before PT-141 is considered, and should be discussed with the prescribing physician. For anyone with known cardiovascular disease (coronary artery disease, prior MI, stroke, heart failure, peripheral vascular disease): do not use. For anyone who has not had blood pressure measured recently: check blood pressure before the first dose. A single unrecognized hypertensive episode from PT-141 use in a cardiovascular patient could be life-threatening. This is the most serious safety concern associated with this compound.See section 8.4.
Molecular weight
~1,025 Da. Cyclic structure (lactam bridge between Asp and Lys). CAS: 189691-06-3. Sequence: Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-OH.
Half-life
These structural features give bremelanotide a plasma half-life of approximately 1-2 hours after SubQ injection — longer than most linear peptides.
Evidence
BLimited human data
FDA Approval
Approved June 21, 2019 as Vyleesi — 1.75 mg SubQ auto-injector for acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. The only on-demand FDA-approved treatment for HSDD. NDA 210557.
THE CORE DISTINCTION
PT-141 / bremelanotide works on the BRAIN (MC4R in the hypothalamus), not on blood vessels. PDE5 inhibitors (Viagra, Cialis) work on vascular smooth muscle via nitric oxide. These are mechanistically different. PT-141 is a desire/arousal modulator; PDE5 inhibitors are blood-flow facilitators. This distinction matters for who it works for and why.
Approved Dosing (women)
1.75 mg SubQ injection via pre-filled autoinjector, 45 minutes before anticipated sexual activity. Maximum 1 dose per 24 hours. Maximum 8 doses per month.
Community Dosing (men)
0.5-2 mg SubQ or intranasal, 30-60 minutes before activity. Most community users start at 1 mg. Nasal spray is off-label — no FDA-approved nasal formulation exists for bremelanotide.
Primary Side Effects
Nausea: ~40% on first dose (reduces with subsequent doses). Flushing, headache, injection site reactions. Transient blood pressure increase (typically +6 mmHg systolic). Focal hyperpigmentation in ~1% (may be permanent).
Blood Pressure Warning
ABSOLUTE CONTRAINDICATION: Uncontrolled hypertension or known cardiovascular disease. Bremelanotide transiently increases BP after dosing. This is a hard stop from the FDA label — not a precaution, a contraindication.
Hyperpigmentation Warning
~1% of users develop focal skin darkening (face, gums, breasts). More common in darker-skinned individuals. In approximately half of affected patients who stopped treatment, it did not reverse. This risk is permanent for some.
Onset / Duration
Onset: 45 minutes (SubQ). Duration: 4-8 hours typical. Effects are desire/arousal focused, not purely vascular — spontaneous erections reported in men even without visual stimulation.
WADA Status
Not currently listed on 2026 WADA Prohibited List. No S0-S5 category covers melanocortin agonists explicitly. Currently accessible to competitive athletes — verify current status before use as lists evolve.
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