Our Pipeline
DEMONSTRATED LEADER IN THE DISCOVERY AND DEVELOPMENT OF MELANOCORTIN AGONIST TREATMENTS
We have only just started tapping into the utility of melanocortin pathways in treating patients after establishing ourselves with Vyleesi® (bremelanotide injection) for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women, as the first FDA-approved melanocortin agent. We are focused on amplifying its commercial platform in North America, supporting commercialization partners globally, and subsequently re-licensing to committed partners in the U.S. and worldwide.
Our development arm builds on our proven success in bringing a melanocortin therapeutic from the lab to market by using our experience to propel our programs in ocular and autoimmune diseases through our clinical pipeline.
Development Programs Overview
clinical
Bremelanotide
clinical
Phase 2 MC4R agonist + GLP-1 in obese patients initiated
Positive topline data reported 1Q25
Novel Once-Weekly Peptide MC4R Agonist
clinical
IND enabling – CMC activities 1Q25 – 4Q25
IND filing 1Q26
Phase 1 SAD/MAD data 1H26
PL7737 Oral Small Molecule MC4R Agonist
clinical
IND enabling – CMC activities 1Q25 – 4Q25
IND filing 1Q26
Phase 1 SAD/MAD data 1H26
PL9643 MCR Agonist
clinical
Phase 3 MELODY-1 completed, positive data
FDA confirmation on protocols and endpoints
Phase 3 Melody-2 & -3 start targeted for 1H26
PL9588 MCR Agonist
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
MCR Agonist
clinical
Phase 2 Open Label Trial
Positive topline data reported 4Q24
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.