This guide provides compounding pharmacies with a comprehensive resource on PT-141 (Bremelanotide). Focused on practical aspects like formulations, dosing, stability, and regulatory compliance, it equips pharmacists and prescribers to deliver high-quality, patient-specific therapies. Whether addressing hypoactive sexual desire disorder (HSDD) or emerging applications in sexual dysfunction, PT-141's central nervous system modulation makes it a valuable peptide for compounding. Explore more at 503pharma.com for peptide education and resources.

What is PT-141?

PT-141, also known as Bremelanotide, is a synthetic cyclic heptapeptide analog of α-melanocyte-stimulating hormone (α-MSH), with the molecular formula C50H68N14O10 and a molecular weight of approximately 1025.2 Da.[1][2] It is a melanocortin receptor agonist with high affinity for MC4R, designed to enhance sexual arousal via central pathways.[3][4] FDA-approved in 2019 as Vyleesi for acquired, generalized HSDD in premenopausal women, it is available as a branded autoinjector but can be compounded for research or off-label use under regulations.[1][5]

Key characteristics for compounding pharmacies include:

• Cyclic Structure: Enhances stability and receptor selectivity compared to linear peptides.[1][6]

• Lyophilized Form: Supplied as a powder for reconstitution, suitable for sterile preparations.[7][8]

• Versatile Delivery: Subcutaneous injection (approved), with potential for nasal or compounded forms.[9][10]

This makes PT-141 suitable for customized therapies in compounding settings.

Mechanisms of Action

PT-141 acts as a non-selective agonist at melanocortin receptors, particularly MC4R in the central nervous system, modulating neurotransmitter pathways to increase sexual desire and arousal.[1][11] It activates excitatory mechanisms in the brain, distinct from peripheral vascular effects of PDE5 inhibitors.[3][12]

Key sub-mechanisms include:

1. Melanocortin Receptor Activation: Binds MC1R, MC3R, MC4R, and MC5R to stimulate appetitive sexual behaviors.[1][13]

2. CNS Modulation: Enhances neural signals in hypothalamic and limbic regions for desire and arousal.[11][14]

3. No Peripheral Vascular Effects: Focuses on central pathways, avoiding direct erectile or vasodilatory actions.[3][15]

4. Neurobiologic Integration: Influences dopamine and other neurotransmitters for integrated sexual response.[1][16]

5. Dose-Dependent Response: As-needed administration allows rapid onset (45 minutes) without hormonal disruption.[1][17]

These mechanisms highlight PT-141's potential for compounding in therapies targeting sexual dysfunction.

Benefits and Applications for Compounding Pharmacies

PT-141 offers targeted benefits when compounded for patient-specific use, particularly in sexual health.[1][18] In compounding pharmacies, it is prepared for applications like HSDD, where it improves desire and reduces distress.[19][20] Benefits include significant enhancements in sexual desire (FSFI-D score increase of 0.35), reduced distress (FSDS-DAO item 13 decrease of 0.33), and increased satisfying sexual events (post hoc 25% vs. 9.8%).[1][21] It is also applied off-label in men for erectile dysfunction and low libido, aiding arousal without vascular focus.[22][23] Additional applications involve potential improvements in overall sexual function and quality of life.[24][25]

Compounding allows customization for these benefits, such as in integrated programs where it enhances outcomes as needed.[26][27]

Below is a table summarizing key benefits, applications, and evidence:

Clinical Studies and Evidence

Clinical evidence for PT-141 includes Phase 3 trials demonstrating efficacy in HSDD, with data up to 2025 confirming benefits in desire and distress.[1][31] Trials show dose-dependent improvements with 1.75 mg SC as needed, achieving co-primary endpoints in premenopausal women.[3][32] Evidence is positive for tolerability, with effects observed early (week 4) and sustained.[12][33] Studies also indicate no abuse potential and safety in recreational users.[34][35]

The table below highlights select key studies:

While robust for approved use, more trials are recommended for off-label applications in men.[22][38]

Clinical Applications

Compounding pharmacies prepare PT-141 for sexual health conditions, with formulations tailored to patient needs like gender or response.[7][39] It is approved for women but used off-label in men for arousal.[40][41]

Key applications include:

• Hypoactive Sexual Desire Disorder: Treats acquired, generalized HSDD in premenopausal women.[1][42]

• Female Sexual Arousal Disorder: Improves arousal in mixed HSDD/FSAD.[28][43]

• Off-Label in Men: Supports libido and ED via CNS pathways.[22][44]

• Sexual Dysfunction Distress: Reduces bother and enhances satisfaction.[1][45]

• Quality of Life Improvement: Addresses interpersonal difficulties from low desire.[21][46]

In compounding, it can be used as nasal sprays or injections for alternative delivery.[9][47]

Compounding Considerations

Compounding pharmacies support PT-141's use beyond branded forms, focusing on sterile preparation, stability, and customization under USP <797> standards.[7][48] This section provides practical guidance for formulations and dosing.

• Injectable Solutions: Compounded at 1.75 mg/0.3 mL, reconstituted with bacteriostatic water; adjust pH to 5-7.[49][50]

• Lyophilized Preparations: Store powder with stabilizers; single-use preferred for sterility.[48][51]

• Standard Dosing: 1.75 mg SC as needed, 45 min before activity; max 1/24h.[1][52]

• Individualized Dosing Considerations: Titrate for tolerance; lower if nausea risks.[53][54]

• Storage and Stability: Lyophilized: 24 months at room temp; reconstituted: 24 hours at 2-8°C.[49][55]

The table below summarizes compounding formulations:

Safety Profile

PT-141's safety profile is established in women with HSDD, with GI effects most common; overall tolerable.[1][57] Compounding pharmacies should emphasize monitoring to ensure quality.

• Clinical Safety Data: No serious toxicity; safe in long-term use for approved indications.[34][58]

• Common Side Effects: Nausea (40%), flushing (20%), headache (11%); transient.[1][59]

• Absolute Contraindications: Uncontrolled hypertension, CVD, hypersensitivity.[60][61]

• Relative Contraindications: Pregnancy, breastfeeding, renal/hepatic impairment.[62][63]

• Monitoring Parameters: BP, heart rate, nausea; check for hyperpigmentation.[64][65]

Regulatory Status

• FDA Classification: Approved as Vyleesi for HSDD in premenopausal women; biologics license.[66][67]

• Legal Considerations: Patient-specific compounding under 503A/B; document necessity for off-label (e.g., men).[68][69]

• Quality Standards: CGMP compliance, sterility; FDA monitors unapproved uses.[66][70]

Clinical Monitoring and Outcomes

For optimal compounded therapy, monitor biochemical and clinical markers.[1][71]

• Biochemical Parameters: Hormones if needed, metabolic panels.[72][73]

• Clinical Outcomes: Desire/distress scores (FSFI, FSDS), SSEs.[1][74]

Timeline of effects:

• Early (first use): Onset in 45 min, arousal improvement.[1]

• Intermediate (4-8 weeks): Sustained desire/distress reduction.[75][76]

• Long-Term (6+ months): Continued benefits, reassess periodically.[77][78]

The table below highlights key monitoring parameters:

Advantages Over Other Therapies

PT-141 offers compounding pharmacies advantages in CNS focus compared to PDE5 inhibitors or hormonal therapies.[81][82]

Physiological Benefits:

• Central arousal without vascular dependence.[1][83]

• No daily dosing; as-needed use.[84][85]

Clinical Advantages:

• Effective in women unresponsive to others.[86][87]

• Minimal hormonal disruption.[88][89]

Pharmaceutical Benefits:

• Stable for compounding in autoinjectors or sprays.[90][91]

• Customizable for gender-specific needs.[92][93]

Future Outlook

Emerging trends include off-label use in men and combinations with other agents; ongoing research focuses on long-term safety and applications in postmenopausal women or ED by 2026.[94][95] New studies explore nasal delivery and broader sexual health indications.[96][97]

Conclusion

PT-141 represents a specialized tool for compounding pharmacies, offering CNS-mediated therapy for sexual dysfunction. By focusing on quality formulations, dosing precision, and regulatory compliance, professionals can enhance patient outcomes in intimate health. At 503pharma.com, we advocate for evidence-based compounding—consult prescribers and stay informed on peptide advancements.

References

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2. Bremelanotide - DrugBank Online. https://go.drugbank.com/drugs/DB11653

3. PT-141: a melanocortin agonist for the treatment of sexual dysfunction. Drugs Today (Barc). 2003;39(5):363-9. https://pubmed.ncbi.nlm.nih.gov/12851303/

4. Bremelanotide for Treatment of Female Hypoactive Sexual Desire. Drugs Today (Barc). 2022;58(1):33-50. https://pubmed.ncbi.nlm.nih.gov/35107039/

5. FDA. Vyleesi (bremelanotide injection) Prescribing Information. 2019. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210557s000lbl.pdf

6. Bremelanotide: First Approval. Drugs. 2019;79(14):1599-1606. https://pubmed.ncbi.nlm.nih.gov/31429031/

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98. PT-141 Therapy for Low Libido. Berman Sexual Health. 2025. https://bermansexualhealth.com/pt-141/

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