Our Pipeline
DEMONSTRATED LEADER IN THE DISCOVERY AND DEVELOPMENT OF MELANOCORTIN AGONIST TREATMENTS
We are a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems. Our primary focus is the development of differentiated and novel ‘next generation’ melanocortin-4 receptor (“MC4R”) selective agonists for obesity therapies targeting rare MC4R pathway disorders with a primary focus on hypothalamic obesity and Prader-Willi syndrome.
Development Programs Overview
clinical
PL7737 Oral Small Molecule MC4R Agonist
clinical
IND enabling –CMC activities ongoing
IND filing 1H26
Phase1 SAD/MAD start 1H26 / data 2H26
Novel Once-Weekly Peptide MC4R Agonist
clinical
IND enabling –CMC activities ongoing
IND filing 2H26
Phase1 SAD/MAD start 2H26 / data 1H27
Bremelanotide
Proof-of-concept study only
clinical
Phase 2 MC4R agonist + GLP-1 in obese patients initiated
Positive topline data reported 1Q25
PL9643 MCR Agonist
clinical
Phase 3 MELODY-1completed, positive data
Phase 3 Melody-2 & -3 potential initiation 2026
Sublicense Agreement with Altanispac Labs
January 2026
Proprietary MCR Agonists
clinical
Research Collaboration / License Agreement with Boehringer Ingelheim
August 2025
PL9654 MCR Agonist
clinical
Research Collaboration / License Agreement with Boehringer Ingelheim
August 2025
PL8177 Oral MC1R Agonist
clinical
Phase 2 Proof-of-Concept
Positive topline data reported 1Q25
Discussions ongoing
MCR Agonist
clinical
Phase 2 Open Label Trial
Positive topline data reported 4Q24
Discussions ongoing
PIONEERING A NEW TREATMENT PARADIGM
FOR OCULAR DISEASES
The need for innovative treatments for ocular indications remains unmet. Specifically, dry eye disease (DED) is a chronic, painful, and debilitating inflammatory eye condition that causes irritation, redness, discharge, and blurred vision. Over 20 million people in the U.S. are estimated to be living with DED.
Palatin is developing a truly novel class of drugs that selectively bind to melanocortin receptors (MCR), with both MCR1 and pan-agonists, to directly activate natural pathways that resolve disease inflammation in the eye. Melanocortin agonists provide potential advantages over current options to better meet the needs of patients and clinicians by directly addressing harmful inflammation, resulting in rapid, global improvement of affected tissues.
Our PL9643 ophthalmic solution (topical eye drops) is currently undergoing late-stage Phase 3 clinical development. Our Phase 2 study demonstrated improvements in both the signs and symptoms of DED after just 2 weeks of treatment, with no safety signals and excellent tolerability.
Additional melanocortin receptor agonists are under investigation to resolve other inflammatory ocular diseases, including non-infectious uveitis, diabetic retinopathy, and diabetic macular edema.
ADVANCING A NOVEL APPROACH TO TREATING AUTOIMMUNE DISEASES
There’s incredible potential to address the underlying inflammation in autoimmune diseases that physicians commonly treat with broad immunosuppressants that increase the risk of complications. The presence of high MCR1 levels in the gut makes ulcerative colitis (UC) a target for melanocortin receptor agonist therapy. This will benefit the nearly 1 million people in the U.S. who suffer from an autoimmune disease that manifests as chronic inflammation of the colon.
Our oral MCR1 agonist (PL8177) was developed to resolve inflammation directly in the colon, avoiding broad immunosuppression and adverse effects with our potent, selective compound. This delayed-release, oral formulation is designed to deliver drug to diseased bowel, maximizing local treatment while avoiding systemic adverse effects.
Two Phase 1 studies have produced promising results. The first demonstrated significant safety and tolerability of PL8177; the second highlighted the value of an oral, delayed-release polymer formulation that can achieve local release without systemic absorption. PL8177 has advanced and is now being investigated in a Phase 2 clinical trial.