Melanocortin receptors (MCR) Therapies- Target Population, Competitive Landscape, and Market Forecast - 2034

Key Highlights:

• MCR therapies involve targeting the five types of MCRs (MC1R to MC5R) to modulate various physiological processes and treat a range of conditions MCRs are G-protein coupled receptors that regulate a wide range of physiological processes.
• Among these five types of MCR therapies MC1R, MC2R, and MC4R are prominently worked on while MC3R and MC5R are not being targeted as compared to others.
• The efficacy of MCR agonists has been tested in various indication types, including Obesity due to POMC, PCSK1 or LEPR deficiency, Hypoactive sexual desire disorder (HSDD) in premenopausal women, Erythropoietic protoporphyria (EPP), Dry Eye Disease, Acquired hypothalamic obesity, Cushing's syndrome, Bardet-Biedl syndrome (BBS) and Congenital Adrenal Hyperplasia (CAH).
• There are currently three approved therapies targeting MCR IMCIVREE (setmelanotide) by Rhythm Pharmaceuticals, VYLEESI (bremelanotide) by Cosette Pharmaceuticals, and SCENESSE (afamelanotide) by Clinuvel Pharmaceuticals, together representing the current market landscape of approved MCR-targeted therapies across metabolic, sexual, and rare dermatological indications.
• MCR therapies have a robust pipeline across MC1R-MC5R, targeting diverse indications like dry eye disease (PL9643, MC1R/MC5R), and Cushing's syndrome (Atumelnant, MC2R), reflecting broad therapeutic potential in metabolic, inflammatory, and endocrine disorders.
• Rhythm Pharmaceuticals, Palatin Technologies, Crinetics Pharmaceuticals, Perspective Therapeutics, and several other companies are currently engaged in the development and production of selective MCR therapies, which have the potential to significantly impact and enhance the MCR therapies market.

DelveInsight's "Melanocortin receptors (MCR) Therapies- Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the MCR, historical and Competitive Landscape as well as the MCR Therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The MCR therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM MCR therapies market size from 2020 to 2034. The report also covers current MCR therapies treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020-2034

MCR therapies Understanding

MCR therapies Overview

The melanocortin receptors are members of the superfamily of G-protein-coupled receptors that are identified by seven transmembrane domains. Mutagenesis studies have identified transmembrane domains one, two, three, six, and seven to be important for receptor binding. To date, five melanocortin receptors (MC1R-MC5R) have been cloned and have now been implicated in several human diseases.

Melanocortin receptors are activated by one or more of the melanocortin peptides (ACTH, a-, or g- MSH). Melanocortin signaling activates adenylate cyclase, increasing the levels of intracellular cyclic adenosine monophosphate (cAMP). The increased levels of cAMP are responsible for the physiological functions elucidated by the melanocortins. Depending on the cell type and the melanocortin receptor expression, signal transduction pathways other than intracellular cyclic adenylyl monophosphate (cAMP) signaling may be activated by melanocortin ligands, including increased intracellular calcium ion levels via the inositol triphosphate pathway or influx of extracellular calcium ions, mitogen-activated protein (MAP) kinase signaling, Janus kinase or signal transducer and activator of transcription (STAT) pathways or the protein kinase C pathway. The mechanisms by which these pathways might be activated by G-protein coupled receptors, such as the MCR, have not been elucidated, and no studies have explored the possible action of the MCR antagonists on these pathways.

MCR therapies Epidemiology

The MCR therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indication for MCR therapies, total eligible patient pool for MCR therapies in selected indication, total treated cases in selected indication for MCR therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• Approximately 10% of women in the U.S. are affected by Hypoactive Sexual Desire Disorder (HSDD). Its prevalence varies by age, affecting 8.9% of women aged 18-44, rising to 12.3% among those aged 45-65, and occurring in 7.4% of women aged 65 and older.
• Dry Eye Disease (DED) shows a notable age-related disparity in prevalence: 8.4% of individuals under 60 report a diagnosis, compared to 15% among those aged 70-79 and 20% in individuals over 80.
• In the US, females were observed to have higher cases of Cushing's Syndrome, than males in 2024.

In 2024, the US reported the highest prevalence of CAH among the 7MM, representing 48% of all cases.

MCR therapies Drug Chapters

The drug chapter segment of the MCR therapies reports encloses a detailed analysis of late-stage (Phase III, Phase II, and Phase I) pipeline drugs. It also helps understand the MCR therapies clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

IMCIVREE (Setmelanotide): Rhythm Pharmaceuticals

IMCIVREE is a melanocortin-4 (MC4) receptor agonist approved for chronic weight management in adult and pediatric patients aged 6 years and older with obesity resulting from deficiencies in proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR). Eligibility requires genetic confirmation of pathogenic, likely pathogenic, or variants of uncertain significance (VUS) in the POMC, PCSK1, or LEPR genes.

Setmelanotide selectively activates the MC4 receptor, with significantly reduced activity-about 20-fold lower-at MC3 and MC1 receptors. MC4 receptors, located in the brain, play a central role in controlling hunger, satiety, and energy expenditure. In individuals with POMC, PCSK1, or LEPR deficiency, impaired MC4 receptor activation can disrupt appetite regulation and energy balance. Setmelanotide may help restore this pathway, leading to reduced hunger and promoting weight loss by decreasing caloric intake and increasing energy expenditure.

Preclinical studies highlight the key role of MC4 receptors in setmelanotide's regulation of appetite and weight. Unlike MC4, the MC1 receptor affects skin pigmentation through melanin production. Setmelanotide is in Phase II and III trials for rare genetic and hypothalamic obesity disorders involving POMC and LEPR deficiencies, Prader-Willi syndrome, hypothalamic obesity, and other conditions linked to MC4R pathway dysfunction.

VYLEESI (Bremelanotide): Cosette Pharmaceuticals

VYLEESI is a melanocortin receptor (MCR) agonist approved for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). This condition is defined by persistently low sexual desire that causes significant distress or interpersonal difficulty and is not attributable to a medical or psychiatric condition, relationship issues, or the effects of medication or drugs.

Bremelanotide, the active ingredient in VYLEESI, nonselectively activates multiple MCR subtypes in the following potency order: MC1R, MC4R, MC3R, MC5R, and MC2R. At therapeutic doses, its activity is primarily relevant at MC1R and MC4R. MC4R-expressing neurons are widely distributed throughout the central nervous system and may play a role in modulating sexual desire, though the exact mechanism by which VYLEESI works in HSDD remains unknown. MC1R is expressed on melanocytes and is associated with increased melanin production and skin pigmentation.

Emerging Drugs

PL9643: Palatin Technologies

PL9643 is a synthetic, topically applied melanocortin receptor (MCR) agonist developed to modulate inflammation on the ocular surface, primarily through MC1R and MC5R activation. These receptors play key roles in immunomodulatory and anti-inflammatory processes. By mimicking natural melanocortins, PL9643 promotes the resolution of inflammation without inducing immunosuppression. This unique mechanism targets both the inflammatory and neurological components of dry eye disease (DED), a multifactorial condition affecting the tear film and ocular surface.

In October 2023, Palatin Technologies reported positive top-line results from the Phase III MELODY-1 trial, demonstrating that PL9643 met its primary and multiple secondary endpoints in patients with moderate to severe DED. Unlike traditional therapies such as corticosteroids or cyclosporine, PL9643's melanocortin-based mechanism offers a novel, first-in-class approach in ophthalmology.

PL9643 is in Phase III for moderate to severe dry eye disease, having met primary and secondary endpoints in the MELODY-1 trial.

MCR Therapies Market Outlook

The melanocortin receptor therapy landscape is undergoing a strategic evolution, marked by the coexistence of established, approved therapies and an increasingly diverse pipeline of targeted candidates. Leading the current market is IMCIVREE (setmelanotide) from Rhythm Pharmaceuticals, a subcutaneous MC4R agonist approved in 2020 for rare genetic forms of obesity due to POMC, PCSK1, or LEPR deficiencies. With orphan drug designation and a precision-medicine approach to patient stratification, IMCIVREE has secured a strong foothold in the rare disease segment. Its continued label expansion into broader hypothalamic and monogenic obesity syndromes positions it for sustained leadership and potential market growth, especially as competitors remain in earlier clinical phases.

Another approved therapy, VYLEESI (bremelanotide), developed by Cosette Pharmaceuticals and approved in 2019, addresses HSDD in premenopausal women through MC4R activation. Although its commercial performance has been modest, it remains differentiated by its on-demand dosing and unique mechanism in a category with limited pharmacological options. In the dermatology space, SCENESSE (afamelanotide), an MC1R agonist from Clinuvel Pharmaceuticals, also approved in 2019, serves a rare indication-erythropoietic protoporphyria (EPP). Its subcutaneous implant and photoprotective benefits support its premium pricing and reinforce its position in a virtually competition-free niche.

On the development front, pipeline activity is increasingly focused on expanding MCR modulation into more prevalent and underserved conditions. PL9643, a topically administered MC1R/MC5R agonist from Palatin Technologies, is in Phase III trials for DED, a widespread and multifactorial condition with a significant unmet need. With a non-immunosuppressive mechanism distinct from conventional agents like cyclosporine or lifitegrast, PL9643 may offer both efficacy and tolerability advantages. If approved, it would mark the first MCR-targeted therapy in ophthalmology, potentially establishing a new treatment paradigm and broadening the class's market relevance.

Also notable is Bivamelagon (LB54640), an oral MC4R agonist under development by Rhythm Pharmaceuticals for acquired hypothalamic obesity. Positioned as an extension of the IMCIVREE platform, Bivamelagon targets patients without monogenic obesity but with hypothalamic injury, such as those affected by surgery or radiation. Its oral formulation offers a more convenient alternative to subcutaneous therapies and could enable Rhythm to capture a larger share of the obesity market by reaching a wider, non-orphan patient population.

Meanwhile, Atumelnant (CRN04894) from Crinetics Pharmaceuticals introduces a novel mechanism by selectively targeting MC2R, the ACTH receptor. Currently in Phase II for Cushing's syndrome and CAH, Atumelnant represents a shift from chronic steroid-based regimens to a more targeted, non-steroidal endocrine therapy. Success in these indications could disrupt long-standing treatment paradigms where safety concerns around glucocorticoids remain a major limitation.

Looking forward, market leadership in rare obesity will likely remain with setmelanotide due to its established efficacy, first-to-market advantage, and expanding indication base. However, next-generation candidates like PL9643 and Bivamelagon signal a shift toward broader therapeutic applicability, particularly in high-prevalence diseases. This transition, coupled with innovation in delivery formats-such as oral and topical routes-reflects a growing emphasis on patient convenience and adherence, which could enhance market adoption.

In summary, while the current MCR therapy market is dominated by high-value, niche indications, the emerging pipeline is positioned to expand the class into mainstream disorders. This evolution signals a potential inflection point, where MCR-targeted drugs could move from orphan exclusivity toward broader commercial and clinical relevance in the coming years.

MCR therapies Drugs Uptake

This section focuses on the uptake rate of potential emerging MCR therapies expected to be launched in the market during -2034.

MCR therapies Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.

The presence of numerous drugs under different stages is expected to generate immense opportunity for MCR therapies market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for MCR therapies.

KOL Views

To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on MCR's evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as Massachusetts General Hospital, Harvard Medical School, University of Oxford, INSERM, University Hospital of Leipzig, University of Padua, University of Illinois Health, Hospital Universitario Ramon y Cajal, National Center for Global Health and Medicine, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or MCR therapy market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug.

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Key Updates on MCR Therapies

• In May 2025, Palatin Technologies presented promising Phase III MELODY-1 trial results at ARVO 2025, highlighting breakthrough symptom resolution with PL9643 in patients with dry eye disease.
• Rhythm Pharmaceuticals reported topline results from its Phase II trial of oral MC4R agonist bivamelagon in its Q1 2025 financial update, also in May 2025.
• In February 2025, SCENESSE was found to be well tolerated across both adolescent (12-17 years) and adult patients in the CUV052 study for erythropoietic protoporphyria (EPP), with no unexpected safety issues observed.
• Also in February 2025, Palatin announced the completion of treatment for the final patient in Phase II BMT-801 study, evaluating a combination of MC4R agonist bremelanotide and GLP-1/GIP dual agonist tirzepatide for obesity. Topline results are expected in Q2 2025.
• In January 2025, Crinetics Pharmaceuticals released positive topline data from a Phase II open-label study of atumelnant, a novel oral ACTH receptor antagonist, for classic congenital adrenal hyperplasia (CAH) and ACTH-dependent Cushing's syndrome.
• In July 2024, the European Commission expanded the marketing authorization for IMCIVREE (setmelanotide) to include children as young as 2 years old, further broadening its rare obesity indication.
• In January 2024, Cosette Pharmaceuticals completed its acquisition of VYLEESI from Palatin Technologies, enhancing its portfolio in female sexual health.

The abstract list is not exhaustive, will be provided in the final report

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of the MCR, explaining its mechanism, and therapies (emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the MCR therapies market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM MCR therapies market.

MCR Therapies Report Insights

• MCR therapies Targeted Patient Pool
• Therapeutic Approaches
• MCR therapies Pipeline Analysis
• MCR therapies Market Size and Trends
• Existing and Future Market Opportunity

MCR Therapies Report Key Strengths

• 10 years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

MCR Therapies Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the MCR therapies total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for MCR therapies?
• What are the risks, burdens, and unmet needs of treatment with MCR-based therapies? What will be the growth opportunities across the 7MM for the patient population of MCR-based therapies?
• What are the key factors hampering the growth of the MCR therapies market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for MCR therapies?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the MCR Therapies Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.