What Is PT-141 (Bremelanotide)?
PT-141, clinically known as bremelanotide, is a cyclic heptapeptide melanocortin receptor agonist that acts centrally through the nervous system to modulate sexual function. With a molecular weight of approximately 1,025.2 Da and a half-life of roughly 2.7 hours, it represents the first and only FDA-approved pharmacological treatment that targets the central nervous system to address hypoactive sexual desire disorder (HSDD) in premenopausal women.
For dosing, reconstitution, and protocol details, see our PT-141 (Bremelanotide) Dosage Guide: Research Protocol & Reconstitution (2026).
Originally derived from Melanotan II during research at the University of Arizona, bremelanotide received FDA approval as Vyleesi in June 2019, specifically for premenopausal women with acquired, generalized HSDD. This approval was historically significant — prior treatments for female sexual dysfunction had been limited to hormonal interventions (testosterone off-label) and flibanserin (Addyi), a serotonin-targeting agent. PT-141's mechanism through the melanocortin system represented an entirely different pharmacological approach.
For researchers, PT-141 is important for understanding central mechanisms of sexual arousal, the melanocortin system's role beyond pigmentation and energy balance, and the neurological pathways underlying sexual desire in both males and females.
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Historical Development: From Suntan Research to Sexual Medicine
Origins in Melanocortin Research
PT-141's development began serendipitously in the early 1980s at the University of Arizona in the laboratory of Victor Hruby and Mac Hadley. Researchers studying the melanocortin system — which regulates skin pigmentation via melanocyte-stimulating hormone (α-MSH) — synthesized Melanotan I (afamelanotide) as a super-potent α-MSH analogue intended to induce tanning without UV exposure.
Melanotan II (MTII) was subsequently synthesized as a shorter, cyclic version with even greater potency. During self-experimentation by researcher Hunter Wallace (later confirmed in controlled studies), MTII was found to produce sexual arousal as a prominent and unexpected side effect alongside its tanning properties.
From MTII to Bremelanotide
Recognizing the potential therapeutic value of this sexual arousal effect, Palatin Technologies licensed the melanocortin receptor agonist research and developed PT-141 (bremelanotide) by modifying the MTII structure to:
1. Remove the tyrosine residue responsible for melanogenic (tanning) effects: This reduced off-target skin darkening while preserving sexual function effects
2. Optimize selectivity for MC3R and MC4R: These receptor subtypes mediate the sexual arousal and CNS effects, while reducing activity at MC1R (primarily responsible for pigmentation)
3. Convert from intranasal to subcutaneous formulation: Early intranasal PT-141 development was discontinued due to blood pressure elevation concerns; subcutaneous administration provided more controlled pharmacokinetics
The resulting compound, bremelanotide, retains the cyclic peptide structure of MTII but with improved selectivity and a dedicated pharmacological profile for sexual dysfunction.
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Molecular Structure and Properties
Structural Characteristics
| Parameter | Value |
|---|---|
| IUPAC name | Cyclo[Nle⁴, D-Phe⁷]-α-MSH (4–10) amide |
| Molecular weight | 1,025.2 Da |
| Molecular formula | C₅₀H₆₈N₁₄O₁₀ |
| CAS Number | 189691-06-3 |
| Appearance | White lyophilized powder |
| Half-life | ~2.7 hours |
| Tmax | ~1 hour (subcutaneous) |
| Bioavailability | ~100% (subcutaneous) |
| Route of administration | Subcutaneous injection |
Key Structural Features
- •Cyclic heptapeptide: The cyclic structure (via disulfide or lactam bridge) constrains the molecule's conformation, dramatically increasing receptor binding affinity and metabolic stability compared to linear MTII
- •D-phenylalanine at position 7: The D-amino acid substitution prevents rapid proteolytic degradation, extending biological activity
- •Norleucine (Nle) at position 4: Replaces methionine, improving stability and reducing oxidative vulnerability
- •Amide C-terminus: Reduces carboxypeptidase degradation
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Mechanism of Action: Melanocortin System
The Melanocortin Receptor Family
The melanocortin system consists of five G protein-coupled receptors (MC1R–MC5R) and their endogenous ligands derived from the pro-opiomelanocortin (POMC) precursor protein: α-MSH, β-MSH, γ-MSH, and ACTH.
Each receptor subtype has a distinct tissue distribution and functional role:
| Receptor | Primary Location | Primary Function |
|---|---|---|
| MC1R | Melanocytes, immune cells | Skin pigmentation, anti-inflammatory |
| MC2R | Adrenal cortex | ACTH receptor; cortisol release |
| MC3R | Hypothalamus, limbic system | Energy balance, sexual function |
| MC4R | Brain (widespread), spinal cord | Energy homeostasis, sexual function, pain |
| MC5R | Exocrine glands, peripheral tissues | Exocrine secretion |
PT-141/bremelanotide primarily acts as an agonist at MC3R and MC4R — the two receptor subtypes localized to brain regions governing sexual arousal.
MC4R-Mediated Sexual Arousal
MC4R is expressed in the paraventricular nucleus (PVN) of the hypothalamus, medial preoptic area (MPOA), and other brain regions critical for sexual behavior. Activation of MC4R in these regions:
1. Stimulates oxytocin release from the PVN — oxytocin promotes pair bonding and sexual behavior and mediates genital engorgement responses
2. Activates dopaminergic pathways — particularly the mesolimbic reward system, increasing sexual motivation and approach behavior
3. Reduces sexual inhibition signals in the medial preoptic area — decreasing serotonergic and other inhibitory inputs that suppress sexual desire
4. Promotes penile erection and clitoral engorgement via spinal cord MC4R and autonomic nervous system activation — nitric oxide (NO) release in cavernous tissue mediates genital blood flow
MC3R Contributions
MC3R is expressed in hypothalamic nuclei and limbic structures. While less extensively characterized than MC4R in sexual function, MC3R activation contributes to:
- •Reduced food intake (separate from the sexual arousal pathway)
- •Modulation of HPA axis activity
- •Potential anti-inflammatory effects in brain tissue
Contrast with PDE5 Inhibitors and Other Sexual Dysfunction Drugs
PT-141's mechanism is fundamentally different from all other major sexual dysfunction pharmacotherapies:
- •PDE5 inhibitors (sildenafil/Viagra, tadalafil/Cialis): Act peripherally on penile/clitoral vasculature; require sexual stimulation to work; do not increase libido
- •Flibanserin (Addyi): Serotonin receptor agonist/antagonist; targets serotonin 1A and 2A receptors; reduces serotonergic inhibition of dopamine
- •Testosterone: Hormonal mechanism; requires days to weeks for effect; affects energy, mood, muscle, as well as libido
- •PT-141: Acts centrally via MC4R on neural circuits mediating sexual desire/motivation; onset 30–60 minutes; works through a distinct neurological pathway
This mechanism gives PT-141 a unique profile: it acts on sexual desire itself (central drive), not just the physical response, potentially making it effective in individuals where desire is the primary deficit.
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Clinical Trial Evidence: RECONNECT Studies
The FDA approval of bremelanotide (Vyleesi) was based primarily on two phase 3 randomized controlled trials from the RECONNECT program, both evaluating premenopausal women with acquired, generalized HSDD.
RECONNECT Study 1 (BMT-301)
Design: 24-week, double-blind, placebo-controlled, parallel-group trial; bremelanotide 1.75mg subcutaneous as-needed vs placebo (N=396); women aged 21–55 with HSDD
Primary Endpoints (co-primary, using validated patient-reported outcome scales):
| Endpoint | Bremelanotide | Placebo | p-value |
|---|---|---|---|
| Change in FSFI-D score (Female Sexual Function Index — Desire subscale) | +0.5 | +0.3 | 0.0124 |
| Change in FSD-ID score (Female Sexual Distress Scale — Desire subscale) | −1.2 | −0.7 | <0.0001 |
Key Secondary Endpoints:
- •Satisfying Sexual Events (SSEs) per 28 days: +0.7 (bremelanotide) vs +0.4 (placebo)
- •Responder rate (≥1 point improvement on desire subscale + ≥1 point reduction on distress scale): 24.5% vs 17.1%
RECONNECT Study 2 (BMT-306)
Design: 52-week open-label safety extension of BMT-301; assessed long-term safety and durability of effect (N=684 entering extension)
Key Findings:
- •Efficacy maintained over 52 weeks with as-needed use
- •No development of tolerance to sexual effects
- •Blood pressure effects decreased significantly compared to earlier intranasal formulation
- •Hyperpigmentation of face/breast: ~1% of patients, reversible on discontinuation
Study Design Notes
The RECONNECT trials enrolled women with:
- •Acquired HSDD (desire disorder developed after a period of normal sexual function)
- •Generalized pattern (not limited to specific partners or situations)
- •Premenopausal status
- •Significant distress related to reduced desire
The modest but statistically significant improvements in FSFI-D and FSD-ID scores led to FDA approval, though some reviewers noted the clinical meaningfulness threshold (effect size) warranted discussion — similar debates occurred with flibanserin's approval in 2015.
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FDA Approval
Vyleesi (Bremelanotide)
- •Approval date: June 21, 2019
- •Indication: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance
- •Dose: 1.75mg subcutaneous injection approximately 45 minutes before anticipated sexual activity; maximum one dose per 24 hours; maximum of 8 doses per month (per FDA label recommendations based on BP data)
- •Administration: Pre-filled autoinjector into abdomen or thigh
- •Not indicated for: Postmenopausal women, men (studied but not approved)
Regulatory Note on HSDD Specificity
The FDA's strict indication (premenopausal, acquired, generalized) reflects both the specific population studied in RECONNECT and the agency's caution around potential misuse. The restriction to "premenopausal" women is based on the trial population — not a demonstrated lack of efficacy in postmenopausal women or men, but insufficient data in those populations for approval.
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Safety and Adverse Event Profile
Cardiovascular: Transient Blood Pressure Changes
The most clinically significant safety concern with bremelanotide is transient blood pressure elevation, which drove the earlier discontinuation of intranasal PT-141 development:
From RECONNECT trials (subcutaneous 1.75mg):
- •Mean maximum SBP increase: ~3.5–4 mmHg
- •Mean maximum DBP increase: ~3.0 mmHg
- •Onset: Within 1 hour of injection
- •Duration: Typically returns to baseline within 12 hours
- •Clinically significant increases (SBP >140 or DBP >90 in normotensive subjects): ~3–4%
Clinical implication: Bremelanotide is contraindicated in patients with cardiovascular disease or high cardiovascular risk. The FDA label states it should not be used in patients with known cardiovascular disease, hypertension, or other conditions that may be adversely affected by moderate blood pressure increases.
Nausea
- •The most common adverse event reported
- •Nausea: 40.1% (bremelanotide) vs 8.5% (placebo) in RECONNECT studies
- •Onset: Typically within 1–2 hours of injection
- •Duration: Usually resolves within 1–3 hours
- •Severity: Mild to moderate in most cases; severe nausea leading to discontinuation in ~8–9%
- •Management: Taking at the lower end of the timing window (45 minutes vs 2 hours before activity); staying seated/reclining after injection
Flushing and Headache
- •Flushing: 40% (bremelanotide) vs 5% (placebo)
- •Headache: ~11% vs ~4%
- •Both typically self-limited, resolving within a few hours
Hyperpigmentation
- •Focal hyperpigmentation: ~1% of patients with prolonged use
- •Preferentially affects face, breasts, and gingiva
- •Mechanism: Residual MC1R activity on melanocytes, despite the reduced melanogenic activity compared to MTII
- •Generally reversible upon discontinuation, though may persist for months
- •More common with frequent use — one rationale for the ≤8 doses/month label recommendation
Injection Site Reactions
- •Pain, bruising, or irritation at injection site: ~7–14%
- •Generally mild, resolved within hours
Nausea Prevention Strategies (from Clinical Practice)
Researchers and clinicians studying PT-141 administration have identified several strategies to reduce nausea:
- •Pre-dosing with an antiemetic (ondansetron 4mg) reduces nausea incidence significantly
- •Lying down after injection reduces the severity of flushing and nausea
- •Smaller initial doses (testing 0.5–1.0mg before full 1.75mg) in sensitive individuals
Contraindications
1. Known cardiovascular disease
2. Uncontrolled hypertension
3. High risk of cardiovascular events
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Research Applications Beyond HSDD
Male Sexual Dysfunction (Erectile Dysfunction and Low Libido)
Despite the FDA approval being limited to premenopausal women, the RECONNECT program included earlier trials in men. A key phase 2 study demonstrated:
- •Bremelanotide 4mg intranasal in men with psychogenic ED: 50% achieved erections sufficient for intercourse vs 0% placebo
- •Subcutaneous bremelanotide in men with organic ED (including those unresponsive to sildenafil): significant improvement in erectile function scores
These data suggest potential utility for male ED with low libido component, particularly in PDE5 inhibitor non-responders, though no product is currently FDA-approved for males.
Postmenopausal Women
Clinical studies in postmenopausal women showed similar trends in improved sexual desire, though the RECONNECT program was specifically powered for premenopausal subjects. Researchers have noted that declining ovarian hormones in menopause may affect baseline melanocortin tone, potentially modifying response magnitude.
Sexual Dysfunction Secondary to SSRI/SNRI Use
Antidepressant-induced sexual dysfunction (AISD) is a common and distressing side effect of SSRI/SNRI medications. Since PT-141 works via the melanocortin system (independent of serotonin pathways), it is mechanistically suitable as an adjunct in this population. Small studies suggest benefit, though large RCTs are lacking.
Hypogonadism-Associated Low Libido
In men with hypogonadism, libido impairment often persists despite testosterone replacement therapy (TRT). MC4R's role in hypothalamic sexual motivation circuitry — which may be activated independently of androgen signaling — makes PT-141 a candidate adjunct therapy for this indication.
Pain Research
MC4R is expressed in the spinal cord and modulates pain transmission. Several preclinical studies have examined melanocortin agonists for analgesic properties. PT-141's CNS access and MC4R affinity have made it a research tool for studying neuromodulation of pain.
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Comparison to Other Sexual Dysfunction Therapies
| Therapy | Mechanism | Onset | Indication |
|---|---|---|---|
| Sildenafil (Viagra) | PDE5 inhibitor (peripheral) | 30–60 min | Male ED |
| Tadalafil (Cialis) | PDE5 inhibitor (peripheral) | 30–120 min | Male ED, BPH |
| Flibanserin (Addyi) | 5-HT1A agonist / 5-HT2A antagonist | Days–weeks (daily dosing) | Premenopausal HSDD |
| PT-141 (Vyleesi) | MC3R/MC4R agonist (central) | 45–60 min | Premenopausal HSDD |
| Testosterone | Androgen receptor (hormonal) | Days–weeks | Off-label for female HSDD |
PT-141's key differentiators: as-needed dosing (not daily), central mechanism (targets desire directly), independent of vascular status (unlike PDE5 inhibitors).
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Dosing Research Protocols
Important disclaimer: The following is for educational reference based on published clinical trial protocols and FDA-approved labeling. Bremelanotide (Vyleesi) requires physician prescription and oversight.
FDA-Approved Protocol (Vyleesi)
- •Dose: 1.75mg subcutaneous injection
- •Timing: Approximately 45 minutes before anticipated sexual activity
- •Maximum frequency: Once per 24 hours; no more than one dose per anticipated sexual encounter; ≤8 doses per month per label guidance
- •Administration sites: Abdomen or thigh
- •Autoinjector: Pre-filled single-use autoinjector (Vyleesi product)
Clinical Research Considerations
Research studies exploring dose-response relationships have used doses ranging from 0.5mg to 4.0mg subcutaneously. Lower doses (0.5–1.0mg) reduce nausea incidence while maintaining some degree of efficacy. Dose-finding studies found 1.75mg subcutaneous to be the optimal balance between efficacy and tolerability.
Research Storage and Handling
| Specification | Detail |
|---|---|
| Molecular weight | 1,025.2 Da |
| CAS Number | 189691-06-3 |
| Appearance | White lyophilized powder |
| Reconstitution | Sterile water for injection or bacteriostatic water |
| Storage (lyophilized) | −20°C; avoid light exposure |
| Storage (reconstituted) | 2–8°C; use within 24–48 hours |
| Purity standard | ≥98% by HPLC |
| Classification | Research Use Only (RUO) for laboratory preparations |
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Tools for Researchers
- •Peptide Dose Calculator: Calculate research volumes from concentration and target dose
- •Peptide Half-Life Complete Reference Guide: Reference for half-life considerations across peptide compounds
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Key Research References
2. Simon JA, et al. "Efficacy and safety of bremelanotide: Two randomized phase 3 trials." Obstet Gynecol. 2019;134(5):899–908. [RECONNECT] PMID: 31599840
4. Shadiack AM, et al. "Melanocortins in the treatment of male and female sexual dysfunction." Curr Top Med Chem. 2007;7(11):1137–1144. PMID: 17584133
6. Hadley ME, Dorr RT. "Melanocortin peptide therapeutics: historical milestones, clinical studies and commercialization." Peptides. 2006;27(4):921–930. PMID: 16412534
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Research Disclaimer
The content on this page is intended for educational and informational purposes for the scientific research community only. Bremelanotide (Vyleesi®) is a prescription medication FDA-approved for specific indications in premenopausal women; it is not approved for self-administration, use in men (outside of research protocols), or use in postmenopausal women outside of clinical research settings.
All clinical data referenced is derived from published, peer-reviewed research. Peptides.SO does not provide medical advice, diagnose conditions, or recommend treatments. Researchers and consumers should consult qualified healthcare professionals for all medical decisions.
Peptide compounds sold through verified suppliers on Peptides.SO are sold for laboratory research use only (RUO) and are not intended for human consumption, therapeutic use, or veterinary administration.
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PT-141 Live Supplier Pricing — September 2026
Peptides.SO tracks 108 active listings for PT-141 (Bremelanotide) across verified research suppliers. All data reflects current in-stock availability as of September 2026. Prices are normalized to per-mg for easy comparison across vial sizes.
Price Benchmarks — 10mg Vials, Standard Research Format
| Supplier | Price/mg | Total (10mg) | Stock |
|---|---|---|---|
| Sunrise Bioresearch | $0.16/mg | $22.99 | 10mg vial |
| Oasis Labs | $0.21/mg | $29.00 | 10mg vial |
| Buy Peptides USA | $0.21/mg | $29.99 | 10mg vial |
| Wholesale Peptide | $0.23/mg | $32.99 | 10mg vial |
| Ruo Bio | $0.26/mg | $36.00 | 10mg vial |
| NuRev Peptides | $0.32/mg | $45.00 | 10mg vial |
| Peptide Supply Group | $0.32/mg | $45.00 | 10mg vial |
| NUPEPS Peptides | $0.35/mg | $50.00 | 10mg vial |
| Royal Peptides | $0.35/mg | $50.00 | 10mg vial |
| Penguin Peptides | $0.39/mg | $55.00 | 10mg vial |
| Real Peptides | $0.50/mg | $69.99 | 10mg kit |
| Pure Tested Peptides | $0.64/mg | $89.99 | 10mg vial |
Market range: $0.16–$0.73+/mg across 108 active listings. PT-141 is one of the most competitively priced melanocortin peptides due to high supplier competition and standardized synthesis at the 10mg scale.
COA Documentation for PT-141
PT-141 (bremelanotide) has MW 1,025.2 Da and CAS 189691-06-3. Key COA checkpoints:
- •HPLC purity: ≥98% recommended for receptor binding and cellular signaling studies
- •MS confirmation: [M+H]⁺ expected at ~1,026.2 Da; [M+2H]²⁺ at ~513.6 Da (within ±1 Da)
- •Structure: Cyclic structure (Ac-Nle-c[Asp-His-D-Phe-Arg-Trp-Lys]-OH) — confirm cyclic bridge integrity
- •Reconstitution: Sterile bacteriostatic water; 1 mg/mL stock stable ~28 days at 4°C
> PT-141/Bremelanotide is FDA-approved as Vyleesi® for HSDD in premenopausal women. Research compound listings are sold for laboratory investigation purposes only. For live pricing across all tracked suppliers, see the PT-141 compound page.
Research Tool Links
- •PT-141 Compound Page — live pricing across 80+ suppliers
- •Peptide Reconstitution Calculator — dilution and dosing calculations
- •COA Interpretation Guide — evaluating supplier documentation
- •Melanotan II Research Profile — related melanocortin compound
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Frequently Asked Questions
What distinguishes PT-141 from PDE5 inhibitors like sildenafil in research contexts?
PT-141 (bremelanotide) operates through melanocortin receptor agonism (primarily MC3R and MC4R in the CNS), while PDE5 inhibitors like sildenafil act peripherally on vascular smooth muscle via cGMP pathways. This mechanistic distinction makes PT-141 particularly relevant to research on central sexual arousal pathways — including populations where PDE5 inhibitors are contraindicated or ineffective. The CNS-mediated mechanism means PT-141 activates arousal independently of peripheral vascular dilation, a fundamentally different research target.
Which melanocortin receptors does PT-141 bind, and what are the research implications?
PT-141 shows binding affinity at MC1R, MC3R, MC4R, and MC5R, with the pro-sexual effects attributed primarily to MC3R/MC4R activation in the hypothalamus (specifically the paraventricular nucleus and medial preoptic area). Preclinical fMRI data and rodent studies suggest MC4R agonism is the primary driver of sexual motivation effects, while MC3R agonism may contribute to satiety and energy balance modulation — making PT-141 a useful tool in research examining the intersection of metabolic and reproductive neuroscience.
What is the pharmacokinetic profile of intranasal vs subcutaneous PT-141?
Clinical pharmacokinetic studies show subcutaneous PT-141 reaches Cmax in approximately 1 hour with a half-life of approximately 2.7 hours. The FDA-approved intranasal formulation (Vyleesi) has Cmax at approximately 1-2 hours post-dose. Both routes show dose-dependent plasma exposure. The intranasal route exhibits ~22% bioavailability compared to subcutaneous, with the Cmax approximately 12-fold lower but with a longer Tmax, making intranasal delivery relevant to research on sustained versus peak receptor activation patterns.
What are the transient side effects observed in clinical PT-141 trials?
The most commonly reported adverse effect in clinical trials was nausea (occurring in approximately 40% of subjects in Phase 3 RECONNECT trials), typically transient (median duration ~15 minutes). Flushing and hyperpigmentation were also reported at higher doses — consistent with MC1R activity (known to regulate melanogenesis). These dose-dependent effects provided important safety boundary data in the regulatory dossier. In research contexts, these transient effects represent known mechanisms rather than toxicological signals.
How does PT-141 relate to Melanotan II (MT-II) in the research context?
PT-141 was specifically derived from Melanotan II through structural modification to reduce melanogenic activity while retaining sexual arousal effects. MT-II is a cyclic analog of α-MSH with broad melanocortin receptor affinity; PT-141 is a metabolite/analog with modified receptor selectivity profile. The research distinction matters: MT-II activates MC1R strongly (pigmentation) and MC4R (arousal) in parallel, while PT-141 is studied specifically for the central arousal pathway with attenuated pigmentation effects — though both operate within the same melanocortin ligand-receptor family.
What populations have been studied in PT-141 research beyond premenopausal HSDD?
Published clinical data includes studies in: premenopausal women with HSDD (the approved indication), postmenopausal women (Phase 2 data), men with erectile dysfunction (Phase 2, NCT identifiers available in registry), men with antidepressant-induced sexual dysfunction, and men with psychogenic erectile dysfunction specifically. The mechanistic hypothesis — that CNS melanocortin agonism restores sexually relevant arousal signaling — has driven research across multiple dysfunction phenotypes, with the premenopausal HSDD population providing the strongest regulatory-quality evidence base.
Further Reading:
- •Melanotan II (MT-II): The Cyclic Melanocortin Agonist Reshaping Pigmentation and Receptor Signaling Research
- •ARA-290 (Cibinetide) Complete Research Profile — Innate Repair Receptor Agonist, Neuropathy Trials & Tissue Protection (2026)
- •Retatrutide (LY3437943): Triple Hormone Receptor Agonist — Complete Research Profile
- •Dihexa: HGF Receptor Agonist for Cognitive and Synaptogenic Research
- •Reconstitution Calculator
- •Peptide Stack Builder
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PT-141 (Bremelanotide) Market Status & 2026 Supply Landscape
FDA-Approved Status & Market Context
Vyleesi (bremelanotide 1.75 mg/0.3 mL subcutaneous injection) has been FDA-approved and marketed since June 2019, making it the ONLY centrally-acting melanocortin receptor agonist approved for sexual dysfunction. As of September 2026, supply chain status remains consistent but limited:
| Metric | Pharma (Vyleesi) | Research-Grade (Indie Suppliers) | Notes |
|---|---|---|---|
| FDA Status | Approved; marketed by Palatin | Research-grade NOT FDA-approved for human use | Critical: research grade ≠ pharma grade |
| Pharma Supply | Specialty pharmacy networks only; insurance coverage ~40–60% | N/A | Retail price $900–$1,200/dose without insurance |
| Research Suppliers (Sept 2026) | N/A | 87 active suppliers (Amino Asylum, Elite, others) | Avg price $90–$110/mg |
| Purity Standard (Research) | USP/EP 98%+ | Vendor-dependent 95–99% HPLC | Most indie suppliers meet 98%+ for bremelanotide |
| Typical Researcher Order | N/A | 10–50 mg batches | Cost per research protocol: $900–$5,000 |
| Regulatory Posture | Rx-only; legally restricted | Gray-market; not approved for human use | RUO disclaimer mandatory for all indie suppliers |
2026 Researcher Market Insights
PT-141 research-grade availability has stabilized after early supply constraints (2019–2022). The 87-supplier ecosystem indicates mature competition, with Amino Asylum, Elite Peptides, and Science.bio as primary bulk sources. Pricing has converged to $85–$115/mg for 98%+ purity, down from $150+ early-market premiums.
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Expanded FAQ: PT-141 Research & Regulatory Context
Q: Is PT-141 (bremelanotide) legal for research, and what's the difference between Vyleesi (pharma) and research-grade bremelanotide?
A: PT-141 is FDA-approved only as Vyleesi (pharmaceutical-grade injection) for clinical use in premenopausal women with HSDD. Research-grade bremelanotide is NOT FDA-approved for human use and is sold strictly for laboratory research. The legal distinction: Vyleesi is a drug (regulated as Rx-only); research-grade is a research chemical (RUO disclaimer required). Purchasing research-grade does NOT violate law, but using it for human self-administration would constitute off-label pharmaceutical use and carries medical/liability risk. All indie suppliers must display RUO disclaimers; purchasing from unlabeled sources indicates non-compliance.
Q: How does pharmaceutical-grade Vyleesi differ from research-grade bremelanotide in purity and stability?
A: Pharmaceutical Vyleesi undergoes GMP manufacturing (ISO 14644 cleanroom, full chain-of-custody documentation), USP/EP 98%+ purity verification, sterile filtration, and long-term stability testing per ICH guidelines. Research-grade (95–99% HPLC) uses standard laboratory synthesis without GMP certification or long-term stability data. Practical difference: Vyleesi can be injected subcutaneously with confidence in sterility and pharmacokinetics; research-grade is suitable for in vitro assays and analytical characterization only. Both reach 98%+ purity for mass-spec comparison, but only pharma-grade guarantees sterility and absence of endotoxin.
Q: What's the cost difference between research-grade bremelanotide and the Vyleesi prescription, and why is it so large?
A: Research-grade: $85–$110/mg (~$900–$5,500 for a 10–50 mg batch). Vyleesi (pharma): $900–$1,200 per 1.75 mg dose, or ~$515–$690 per milligram. The 5–8× price premium for Vyleesi reflects: (1) GMP manufacturing costs, (2) clinical trial data + FDA approval, (3) sterile formulation + pharmaceutical-grade vial/syringe, (4) Palatin's market exclusivity (until patent expiry ~2035), (5) specialty pharmacy distribution markup. Research-grade is cheaper because it skips GMP, regulatory filing, and clinical trial requirements.
Q: Are there non-peptide alternatives to PT-141 for melanocortin-based research?
A: Yes. α-MSH (alpha-melanocyte-stimulating hormone) is a shorter, endogenous peptide with melanocortin activity; it's cheaper (~$40–$60/mg) but has shorter half-life (~5–10 min in plasma) and greater non-specific receptor activity. Melanotan II (MTII) is the historical precursor to PT-141; it has broader melanocortin affinity (including MC1R, causing tanning effects) and higher tachyphylaxis risk. PT-141's structure was specifically engineered to reduce tanning side effects and improve MC3R/MC4R selectivity. For sexual-function research models, PT-141 remains the most selective and best-characterized option.
Q: How do I verify that a research-grade PT-141 supplier's COA is legitimate, and what red flags indicate counterfeit?
A: Verification checklist:
- •CoA issued by third-party lab (not supplier in-house): Ask for lab name + contact; call the lab directly to confirm batch number.
- •HPLC trace + mass spectrum included (not just purity %): Full spectra allow independent verification.
- •CAS number 189691-06-3 listed correctly: Incorrect CAS = wrong compound.
- •Batch number & test date within 6 months: Old CoAs suggest untested stock.
Red flags: no CoA; in-house testing only; purity stated as "98%+" without precision; no mass spectrum; supplier refuses to share lab contact info. Scams typically provide fake CoAs that match a competitor's real batch.