Pipeline
The melanocortin pipeline
From zero approved melanocortin medicines before 2019 to four today— with a deepening pipeline of agonists and antagonists behind them. A dated snapshot of where the field stands.
- 4 Approved
- 2 Phase 3
- 4 Phase 2
- 3 Discovery
- 1 Paused
Rare genetic & hypothalamic obesity · Rhythm · Expanded to acquired hypothalamic obesity in 2026 (Phase 3 TRANSCEND)
Erythropoietic protoporphyria · Clinuvel
Hypoactive sexual desire disorder · Palatin
Infantile spasms · MS relapses · sarcoidosis · Mallinckrodt
Erythropoietic protoporphyria / XLP · Tanabe · Phase 3 INSPIRE met its primary endpoint (2026); would be the first oral EPP therapy if approved
Dry eye disease · Palatin · MELODY-1 Phase 3 hit its co-primary symptom endpoint; remaining MELODY trials ongoing
Obesity (combination) · Palatin · Phase 2 (BMT-801) met its primary endpoint in 2025; low-dose MC4R activation added to a GLP-1 also curbed weight regain
Ulcerative colitis · Palatin · Positive Phase 2 topline (2025); Palatin capped enrollment to out-license and refocus on its obesity program
Cancer cachexia / wasting · Kalohexis · Appetite-restoring — the mirror of MC4R agonism; Phase 2 in metastatic colorectal-cancer cachexia
Diffuse cutaneous systemic sclerosis · Tanabe · Repurposing MC1R’s anti-inflammatory action
Obesity · Palatin · Oral MC4R agonist entering the clinic (2026) as an obesity monotherapy and GLP-1 add-on
Obesity · Research · Weight loss shown in primate studies
Obesity (cardiovascular-sparing) · Research · Aiming for efficacy without the blood-pressure liability
Erectile dysfunction · Palatin · Intranasal program halted over blood-pressure increases (~2008); later reformulated subcutaneously
Pipeline snapshot, 2026. Phases reflect the furthest stage reached and date quickly; this page is verified against current sources at review. It is informational, not medical or investment advice. Approved agents are detailed in thetherapeutics section.
Common questions
How many melanocortin drugs are approved?
Four are FDA-approved: setmelanotide (MC4R, rare genetic and hypothalamic obesity), afamelanotide (MC1R, erythropoietic protoporphyria), bremelanotide (sexual desire), and the long-standing repository corticotropin / ACTH (inflammatory and seizure indications).
What melanocortin drugs are in clinical trials?
Late-stage candidates include the oral MC1R agonist dersimelagon (positive Phase 3 in protoporphyria) and Palatin’s ophthalmic PL-9643 (Phase 3, dry eye). In Phase 2 are PL-8177 (oral, ulcerative colitis) and the MC4R antagonist TCMCB07 (cachexia), with dual MC3R/MC4R and biased MC4R agonists for obesity in discovery.