Bremelanotide (Vyleesi): A Comprehensive Pharmacological and Clinical Review

Executive Summary

Bremelanotide, marketed as Vyleesi, is a first-in-class melanocortin receptor agonist approved for the treatment of acquired, generalized Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.[1] It represents a novel therapeutic approach, acting centrally on brain pathways associated with sexual desire, in contrast to peripherally acting agents that target vascular response.[3] Administered as an on-demand subcutaneous injection, Bremelanotide offers a distinct alternative to daily oral therapies.[4] Its approval was based on the pivotal RECONNECT Phase 3 clinical trials, which demonstrated statistically significant, albeit modest, improvements in sexual desire and reductions in the distress associated with HSDD when compared to placebo.[5] The safety and tolerability profile is characterized primarily by a high incidence of nausea, transient increases in blood pressure, and a risk of focal hyperpigmentation with frequent use.[1] This report provides a comprehensive review of Bremelanotide, detailing its chemical properties, mechanism of action, clinical evidence, administration protocols, and safety profile, while contextualizing its unique position relative to its main therapeutic alternative, Flibanserin (Addyi).

Section 1: Foundational Profile of Bremelanotide

This section establishes the fundamental scientific identity of Bremelanotide, detailing its chemical nature, pharmacological properties, and pharmacokinetic profile. This foundational knowledge is crucial for understanding its therapeutic effects and side effect profile discussed in later sections.

1.1. Chemical Identity and Structure

Bremelanotide is a biotech drug classified as an oligopeptide, specifically a synthetic analog of the endogenous neuropeptide hormone alpha-melanocyte-stimulating hormone ($\alpha$-MSH).[7] Structurally, it is a cyclic heptapeptide lactam, a configuration that enhances its stability.[1] It is identified as an active metabolite of melanotan II, from which it differs by the lack of a C-terminal amide group.[1]

The specific amino acid sequence of Bremelanotide is Ac-Nle-cyclo-OH.[1] This structure is also designated by the substitutional name cyclo-Ac-$\alpha$-MSH-(4-10).[1]

Key molecular and commercial identifiers are as follows:

• Molecular Formula: $C_{50}H_{68}N_{14}O_{10}$ [7]
• Molecular Weight: 1025.16 g/mol [7]
• CAS Number: 189691-06-3 [7]
• DrugBank ID: DB11653 [11]
• Synonyms/Investigational Codes: PT-141, PT141, PT 141 [11]
• Brand Name: Vyleesi [1]

Physically, Bremelanotide is a white to off-white solid powder with a relative density of 1.43 g/cm³.[7] The commercially available product is the acetate salt form, Bremelanotide acetate.[12]

1.2. Mechanism of Action and Pharmacodynamics

Bremelanotide functions as a non-selective melanocortin receptor (MCR) agonist.[1] Its therapeutic effect is centrally mediated, modulating neural pathways in the brain that are involved in sexual response.[3] This mechanism is fundamentally different from that of phosphodiesterase type 5 (PDE5) inhibitors, such as sildenafil, which act peripherally to enhance blood flow and are not indicated to increase sexual desire.[3] This distinction defines a separate therapeutic class for sexual dysfunction, one that targets the central nervous system component of "desire" rather than the peripheral physiological component of "performance." This unique mechanism explains why Bremelanotide is currently under investigation for erectile dysfunction in men who do not respond to PDE5 inhibitors, as it may address a non-vascular, centrally-driven aspect of their condition.[3]

Bremelanotide binds to several MCR subtypes with the following order of potency: MC1R > MC4R > MC3R > MC5R > MC2R.[11] Its activity at the MC2 receptor (the receptor for adrenocorticotropic hormone, ACTH) is minimal.[1] Although Bremelanotide has the highest affinity for the MC1R, its therapeutic effect in HSDD is primarily attributed to its agonist activity at the MC3 and MC4 receptors.[3] The MC4R subtype, in particular, is considered the most relevant at therapeutic doses.[20] These receptors are highly expressed in the central nervous system, especially within the medial preoptic area (mPOA) of the hypothalamus, a region known to be critical for modulating female sexual function and behavior.[11]

While the precise downstream cascade linking MCR agonism to an increase in sexual desire is not fully elucidated, the leading hypothesis suggests that Bremelanotide stimulates the release of dopamine in the mPOA.[11] Dopamine is a key neurotransmitter associated with motivation, pleasure, and sexual interest.[22] The therapeutic effect is thought to arise from a rebalancing of central excitatory signals (like dopamine) and inhibitory signals (like serotonin) that regulate sexual desire.[21]

The non-selective nature of Bremelanotide's receptor binding creates an inherent pharmacological trade-off, giving rise to both its therapeutic action and its most notable side effects. The desired pro-sexual effect stems from agonism at MC3R and MC4R in the brain, while the simultaneous agonism at MC1R on melanocytes in the skin leads to increased melanin expression, causing the adverse effect of focal hyperpigmentation.[11] This direct link between the drug's fundamental pharmacology and its clinical risk-benefit profile suggests that a future, more ideal therapeutic agent based on this mechanism would be a highly selective MC4R agonist, designed to retain the pro-sexual effects while minimizing or eliminating the pigmentary side effects.

Beyond its effects on sexual desire and skin pigmentation, Bremelanotide also has distinct pharmacodynamic effects on the cardiovascular system. Each dose causes a transient increase in blood pressure (systolic up to 6 mmHg, diastolic up to 3 mmHg) and a corresponding decrease in heart rate (up to 5 beats per minute). These effects typically peak 2 to 4 hours post-administration and resolve within 12 hours.[1]

1.3. Pharmacokinetics: ADME Profile

The pharmacokinetic profile of Bremelanotide is characterized by rapid absorption and a relatively short half-life, consistent with its as-needed dosing schedule.

• Absorption: Following subcutaneous injection, Bremelanotide is completely absorbed, with 100% bioavailability.[11] The time to reach maximum plasma concentration ($T_{max}$) is approximately 1.0 hour, with a range of 0.5 to 1.0 hours.[11] The peak plasma concentration ($C_{max}$) is 72.8 ng/mL, and the total drug exposure, or area under the curve (AUC), is 276 hr*ng/mL.[11]
• Distribution: The mean volume of distribution is 25.0 ± 5.8 L, and serum protein binding is low at 21%.[11]
• Metabolism: As a 7-amino acid peptide, Bremelanotide is metabolized via multiple hydrolysis reactions.[11] It undergoes minimal hepatic metabolism and does not significantly interact with hepatic microsomal enzymes.[15]
• Excretion: The primary route of elimination is renal, with 64.8% of a dose excreted in the urine and 22.8% recovered in the feces.[11]
• Elimination: The mean terminal half-life is approximately 2.7 hours (range: 1.9-4.0 hours), and the mean clearance is 6.5 ± 1.0 L/hr.[11]

The key pharmacokinetic parameters are summarized in the table below.

Parameter	Value	Source(s)
Bioavailability (Subcutaneous)	100%	11
$T_{max}$ (Time to Peak Concentration)	~1.0 hour (range: 0.5-1.0 h)	11
$C_{max}$ (Peak Plasma Concentration)	72.8 ng/mL	11
AUC (Total Drug Exposure)	276 hr*ng/mL	11
Volume of Distribution ($V_{d}$)	25.0 L	11
Serum Protein Binding	21%	11
Elimination Half-Life ($t_{1/2}$)	~2.7 hours (range: 1.9-4.0 h)	11
Clearance	6.5 L/hr	11
Primary Route of Elimination	Renal (64.8%)	11

Section 2: Clinical Evidence and Therapeutic Application

This section transitions from the drug's basic science to its proven clinical use, detailing the specific patient population for which it is approved and critically analyzing the evidence that supports this indication.

2.1. Approved Indication and Limitations of Use

Bremelanotide is approved by the U.S. Food and Drug Administration (FDA) for a highly specific patient population and condition: the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD).[2]

The diagnostic criteria for HSDD require that the patient experiences low sexual desire that causes marked personal distress or interpersonal difficulty.[2] A crucial element of the diagnosis is the exclusion of other potential causes for the low desire. Therefore, the indication specifies that the condition must NOT be due to:

• A co-existing medical or psychiatric condition [2]
• Problems within the relationship [2]
• The effects of a medication or other drug substance [2]

The indication is further refined to two specific subtypes of HSDD:

• Acquired HSDD: This refers to HSDD that develops in a patient who previously had no problems with sexual desire.[2]
• Generalized HSDD: This refers to HSDD that occurs regardless of the type of stimulation, situation, or partner.[2]

There are also explicit limitations of use. Bremelanotide is not indicated for the treatment of HSDD in postmenopausal women or in men, nor is it indicated to enhance sexual performance.[21]

2.2. Analysis of Pivotal Phase 3 RECONNECT Trials

The FDA approval of Bremelanotide was based on the positive results from two identical Phase 3, randomized, double-blind, placebo-controlled, multicenter clinical trials, collectively known as the RECONNECT studies (Study 301: NCT02333071; Study 302: NCT02338960).[5] These trials evaluated the efficacy and safety of Bremelanotide at a dose of 1.75 mg, administered subcutaneously on an as-needed basis, over a 24-week period. The study population consisted of 1,247 premenopausal women with a diagnosis of HSDD.[5]

The trials assessed two coprimary efficacy endpoints:

1. The change from baseline in the Female Sexual Function Index-desire domain (FSFI-D) score, a measure of sexual desire.[5]
2. The change from baseline in the Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 13, which measures the level of distress a patient feels due to low sexual desire.[5]

The results from both studies demonstrated that Bremelanotide was superior to placebo on both coprimary endpoints. In an integrated analysis of the two trials, women treated with Bremelanotide showed statistically significant increases in sexual desire (treatment effect: 0.35; $p <.001$) and statistically significant reductions in distress related to low sexual desire (treatment effect: -0.33; $p <.001$).[5]

While these results are statistically robust, it is important to contextualize the clinical magnitude of the effect. The data show that the drug works from a statistical standpoint, but its real-world impact may be limited to a subset of patients and may not be dramatic. For example, some analyses of the trial data show that approximately 25% of women treated with Bremelanotide experienced a meaningful increase in their sexual desire score, compared to about 17% of those who received a placebo.[4] This 8-percentage-point improvement over placebo, while significant, highlights the modest nature of the drug's effect. This distinction between statistical significance and clinical meaningfulness has important implications for patient counseling, where managing expectations is paramount to prevent disappointment and ensure appropriate use.

The overall safety profile in the RECONNECT trials was deemed favorable, with most treatment-emergent adverse events being mild or moderate in intensity and related to tolerability.[5] The most commonly reported adverse events were nausea, flushing, and headache.[5]

2.3. Emerging and Investigational Uses

Beyond its approved indication for HSDD, Bremelanotide is being explored for other therapeutic applications, most notably for erectile dysfunction (ED). Palatin Technologies has initiated a Phase 2 clinical study to evaluate Bremelanotide co-administered with a PDE5 inhibitor for the treatment of ED in men who are non-responders to PDE5 inhibitor monotherapy.[18] The rationale for this investigation lies in the potential for synergy between Bremelanotide's central mechanism (enhancing desire and arousal pathways) and the peripheral vascular mechanism of PDE5 inhibitors (enhancing blood flow).[3] A Phase 3 study with a new co-formulated product is anticipated.[18]

Early-stage research has also explored Bremelanotide's potential use in hemorrhagic shock and reperfusion injury.[10] Furthermore, preclinical studies in rodent models have suggested potential neuroprotective activity against ischemic brain injury and an ability to stimulate appetite.[10]

Section 3: Clinical Administration and Patient Management

This section provides practical, actionable guidance for healthcare providers on how to prescribe and manage Bremelanotide therapy effectively and safely.

3.1. Dosage and Administration Protocol

• Recommended Dose: The standard dose is 1.75 mg, delivered as a 1.75 mg/0.3 mL solution.[24]
• Route and Site of Administration: The drug is administered via subcutaneous injection into the abdomen or thigh.[24] Patients should be trained on proper injection technique and instructed to rotate injection sites to help prevent skin problems such as injection site reactions.[24]
• Timing: Bremelanotide is intended for as-needed use and should be administered at least 45 minutes before anticipated sexual activity.[24] The optimal window for administration and the duration of efficacy have not been fully characterized and may vary based on individual patient experience.[21]
• Frequency Limitations: There are strict limits on the frequency of administration to mitigate safety risks:
• Daily Limit: Patients must not use more than one dose within a 24-hour period. This is to minimize the risk of additive effects on blood pressure.[24]
• Monthly Limit: It is not recommended to administer more than 8 doses per month. This limitation is in place to reduce the risk of focal hyperpigmentation and to limit the cumulative duration of blood pressure elevation over the course of a month.[24]
• Delivery Device: The medication is supplied in a single-dose, prefilled autoinjector designed for patient self-administration.[15]

3.2. Patient Counseling and Education

Effective patient management requires thorough counseling on several key aspects of Bremelanotide therapy.

• Discontinuation Criteria: Patients should be informed that if they do not experience an improvement in their symptoms (both sexual desire and associated distress) after 8 weeks of treatment, the medication should be discontinued.[1]
• Managing Side Effects:
• Nausea: Patients must be warned that nausea is a very common side effect, affecting up to 40% of users.[6] It is most likely to occur after the first dose but often improves with subsequent doses.[6] The nausea typically begins within an hour of injection and lasts for about two hours.[6] For patients who are bothered by nausea but wish to continue treatment, an anti-emetic medication may be considered.[6]
• Cardiovascular Effects: Patients should be counseled about the transient increase in blood pressure and decrease in heart rate that occurs after each dose. They should be reassured that these changes typically resolve within 12 hours.[2]
• Hyperpigmentation: The risk of skin darkening on the face, gums, or breasts should be discussed. This risk is higher in individuals with darker skin and increases with more frequent use.[6]
• Pregnancy and Contraception: Bremelanotide has the potential to cause harm to an unborn baby. Therefore, females of reproductive potential must be advised to use an effective form of contraception throughout treatment and to discontinue the medication immediately if they suspect they have become pregnant.[16]
• Storage: Patients should be instructed to store unopened autoinjectors at or below 25°C (77°F), to protect them from light, and to not freeze them.[31]

Section 4: Comprehensive Safety and Tolerability Profile

This section is dedicated to a thorough review of Bremelanotide's safety profile, a critical component for clinical decision-making.

4.1. Adverse Reactions and Incidence

The safety profile of Bremelanotide is dominated by tolerability issues, particularly nausea. Based on integrated data from the Phase 3 RECONNECT trials, the most frequently reported adverse reactions are detailed in the table below.

Adverse Reaction	Bremelanotide 1.75 mg (n=1247)	Placebo	Source(s)
Nausea	40.0%	1.3%	[1, 32]
Flushing	20.3%	1.3%	[1, 32]
Injection Site Reactions	13.2%	Not specified	1
Headache	11.3%	1.9%	[1, 32]
Vomiting	4.8%	Not specified	1
Cough	3.3%	Not specified	1
Fatigue	3.2%	Not specified	1
Hot Flush	2.7%	Not specified	1
Paresthesia	2.6%	Not specified	1
Dizziness	2.2%	Not specified	1
Nasal Congestion	2.1%	Not specified	1

Nausea was the most common reason for treatment discontinuation, leading 8% of patients to stop the therapy.[6] The overall discontinuation rate due to any adverse event was significantly higher in the Bremelanotide group (18%) compared to the placebo group (2%).[2]

4.2. Warnings, Precautions, and Contraindications

The use of Bremelanotide is associated with several important warnings and is contraindicated in certain patient populations.

• Contraindications: Bremelanotide is strictly contraindicated in patients with:
• Uncontrolled hypertension [1]
• Known cardiovascular disease [1]
• Warnings and Precautions:
• Transient Increase in Blood Pressure and Decrease in Heart Rate: This is a consistent pharmacodynamic effect of the drug. Consequently, Bremelanotide is not recommended for patients at high risk for cardiovascular disease. A patient's cardiovascular risk should be assessed before initiating therapy and periodically during treatment, and their blood pressure must be well-controlled.[2]
• Focal Hyperpigmentation: This adverse effect, involving darkening of the skin on the face, gingiva, and breasts, was reported in approximately 1% of patients adhering to the recommended monthly dosing schedule.[2] The risk is elevated in patients with darker skin and with more frequent dosing (e.g., daily use).[6] It is important to note that the resolution of this pigmentation is not guaranteed after the drug is discontinued.[6]
• Nausea: As the most common adverse event, nausea requires significant patient counseling. In clinical trials, 13% of patients experiencing nausea required anti-emetic therapy to manage the symptom.[6]

4.3. Drug Interaction Profile

The primary mechanism for drug interactions with Bremelanotide is pharmacodynamic rather than pharmacokinetic.

• Mechanism of Interaction: Bremelanotide may slow gastric emptying, which can potentially reduce the rate and extent of absorption of concomitantly administered oral medications.[15]
• Clinically Significant Interactions:
• Oral Naltrexone: Concomitant use with Bremelanotide should be avoided. Bremelanotide can significantly decrease the systemic exposure of orally administered naltrexone, which could lead to treatment failure for patients being treated for alcohol or opioid dependence.[4]
• Drugs Dependent on Threshold Concentrations: Caution is advised when co-administering Bremelanotide with oral drugs for which efficacy depends on achieving a certain threshold concentration, such as some anti-infective agents.[15]
• Interactions Not Considered Clinically Significant:
• Alcohol: No clinically significant interaction has been observed between Bremelanotide and alcohol, and alcohol use is not restricted.[11]
• Other Oral Drugs: Studies with other oral medications (including amlodipine, bupropion, celecoxib, and furosemide) showed that Bremelanotide delayed their absorption and decreased their $C_{max}$, but it did not have a clinically important effect on their total exposure (AUC).[15]
• Pharmacokinetic Interactions: As Bremelanotide is metabolized by peptide hydrolysis rather than by hepatic enzymes, pharmacokinetic interactions with drugs that affect or are metabolized by the cytochrome P450 system are unlikely.[15]

4.4. Guidance for Special Populations

• Pregnancy: Based on animal studies, Bremelanotide may cause fetal harm and its use is not recommended during pregnancy. Females of reproductive potential should be advised to use effective contraception and to discontinue the drug if pregnancy is suspected.[16] A pregnancy exposure registry exists to monitor outcomes.[2]
• Breastfeeding: It is unknown if Bremelanotide is excreted in human breast milk, and there are no adequate studies to determine the risk to a nursing infant.[21]
• Renal Impairment:
• Mild-to-moderate impairment (eGFR 30-89 mL/min/1.73 m²): No dosage adjustment is necessary.[25]
• Severe impairment (eGFR <30 mL/min/1.73 m²): The drug should be used with caution, as systemic exposure is increased, which may lead to a higher incidence and severity of adverse reactions like nausea and vomiting.[24]
• Hepatic Impairment:
• Mild-to-moderate impairment (Child-Pugh Class A and B): No dosage adjustment is needed.[25]
• Severe impairment (Child-Pugh Class C): Bremelanotide has not been evaluated in this population and should be used with caution.[25]

Section 5: Comparative Analysis and Clinical Context

This final section synthesizes all the information to place Bremelanotide in its clinical context, primarily by comparing it to its only direct competitor, and provides guidance on patient selection.

5.1. Bremelanotide (Vyleesi) vs. Flibanserin (Addyi): A Head-to-Head Comparison

For the treatment of HSDD in premenopausal women, clinicians and patients have two FDA-approved options: Bremelanotide (Vyleesi) and Flibanserin (Addyi). These drugs differ fundamentally in their mechanism of action, administration, and safety profiles, making a direct comparison essential for informed clinical decision-making.

Feature	Bremelanotide (Vyleesi)	Flibanserin (Addyi)
Mechanism of Action	Melanocortin receptor agonist (centrally acting) [16, 34]	Serotonin 1A receptor agonist / 2A receptor antagonist [34, 35]
Administration/Dosing	As-needed subcutaneous injection (1.75 mg) at least 45 minutes prior to sexual activity [4, 22]	Daily oral pill (100 mg) taken at bedtime, regardless of sexual activity [4, 36]
Onset of Action	Rapid (within 1 hour) [37]	Delayed (may take up to 8 weeks to see an effect) [22]
Indication	Acquired, generalized HSDD in premenopausal women 2	Acquired, generalized HSDD in premenopausal women [35]
Efficacy (vs. Placebo)	~8% improvement in responder rate for sexual desire over placebo 4	~10% improvement in satisfying sexual events over placebo 4
Key Side Effects	Nausea (40%), flushing (20%), injection site reactions (13%), headache (11%), transient hypertension, focal hyperpigmentation [34, 36]	Dizziness (11%), somnolence (11%), nausea (10%), fatigue, risk of severe hypotension and syncope (fainting) [34, 36]
Key Contraindications	Uncontrolled hypertension, known cardiovascular disease [6, 38]	Concomitant use with alcohol, use with moderate/strong CYP3A4 inhibitors, hepatic impairment [36, 39]
Alcohol Interaction	None; alcohol use is not restricted [15, 36]	Significant risk of severe hypotension and syncope; alcohol use must be carefully managed or avoided [23, 36]
Drug Interactions	Few significant interactions; avoid oral naltrexone; may slow absorption of other oral drugs [34, 39]	Many significant interactions, particularly with CYP3A4 inhibitors and CNS depressants [34, 39]

5.2. Clinical Recommendations and Patient Selection

The choice between Bremelanotide and Flibanserin is driven less by a difference in efficacy—as both demonstrate modest benefits over placebo—and more by a fundamental difference in user experience, lifestyle compatibility, and risk tolerance. The clinical decision should be a shared one, tailored to the individual patient's preferences and medical history.

An ideal candidate for Bremelanotide (Vyleesi) is a premenopausal woman with a confirmed diagnosis of acquired, generalized HSDD who prioritizes spontaneity and prefers an on-demand treatment over a daily medication.[37] This patient must be comfortable with the idea of self-injection and must not have any cardiovascular contraindications, such as uncontrolled hypertension. She should be counseled extensively on the high likelihood of experiencing acute side effects, particularly nausea after the initial doses.

Conversely, a suitable candidate for Flibanserin (Addyi) may be a patient who is averse to injections and prefers the convenience of a daily oral pill.[40] This patient must be able to understand and strictly adhere to the significant lifestyle restrictions, most notably the warnings regarding alcohol consumption, due to the risk of severe hypotension and syncope.[36] Her medication profile should also be carefully reviewed to avoid interactions with CYP3A4 inhibitors and other CNS depressants.

Ultimately, pharmacotherapy is only one component of a comprehensive management plan for HSDD. The modest efficacy of both available drugs underscores the importance of a holistic approach that may also include addressing psychological, interpersonal, and relationship factors that can contribute to low sexual desire.[17]

Conclusion

Bremelanotide (Vyleesi) is a novel, centrally-acting melanocortin receptor agonist that represents a significant and mechanistically distinct addition to the limited therapeutic armamentarium for Hypoactive Sexual Desire Disorder in premenopausal women. Its unique position as an on-demand, injectable therapy offers a valuable alternative to daily oral medication, catering to patients who may prefer an event-based treatment paradigm. The clinical evidence supports its efficacy in increasing sexual desire and reducing associated distress, although the magnitude of this effect is modest. This benefit must be carefully weighed against a significant tolerability and safety profile, which includes a high incidence of nausea, transient cardiovascular effects, and the risk of hyperpigmentation. Therefore, Bremelanotide is best positioned as a specialized treatment option that requires careful patient selection, comprehensive counseling to manage expectations and side effects, and a shared decision-making process to align its unique characteristics with the patient's lifestyle and health status.

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