PL7737 / Palatin Technologies - LARVOL DELTA

Characterization of the Melanocortin Receptor 4 Oral Small Molecule Agonist PL7737 (OBESITY WEEK 2025) - "Long-term management of weight loss will require multiple safe and effective mechanisms. We have presented data demonstrating that PL7737 is a potent MC4R agonist that can cause significant weight loss when delivered orally. Preclinical studies indicate that oral PL7737 does not affect blood pressure or prolong the QTc segment."

Genetic Disorders • Obesity • MC4R

Poster #1: PL7737 – Oral MC4R Small Molecule Agonist (PRNewswire) - "Preclinical data demonstrated: Dose-dependent, statistically significant weight loss in diet-induced obese (DIO) mice, with no observed effect on systolic blood pressure; Favorable pharmacokinetic profile, including approximately 50% oral bioavailability and a half-life exceeding three hours in rats; Encouraging safety and tolerability, with no hERG or Ames assay findings and no toxicity observed in a 28-day non-GLP rat study."

Preclinical • Obesity

Ongoing and Future Development (PRNewswire) - "PL7737 (oral MC4R agonist): IND-enabling toxicology studies are ongoing, with an IND filing and initiation of a Phase 1 single- and multiple-ascending dose (SAD/MAD) trial expected in the first half of 2026; Next-generation selective peptide MC4R agonists: Designed for once-weekly subcutaneous dosing, with an IND filing and Phase 1 SAD/MAD trial planned for mid-2026; Phase 1 studies are expected to include patients with hypothalamic obesity."

IND • New P1 trial • Hypothalamic Injury-associated Obesity

Palatin Announces Positive Preclinical Efficacy Data for Oral MC4R Agonist PL7737 in Animal Model of Obesity (PRNewswire) - "Palatin Technologies...announced strong preclinical results for PL7737, an oral selective melanocortin-4 receptor (MC4R) agonist, showing effectiveness in rodent models of obesity....After 4 days of treatment, all results were statistically significant compared to vehicle control: PL7737 - Middle Dose: 5% weight loss; PL7737 - High Dose: 10% weight loss; Tirzepatide Alone: 5% weight loss; PL7737 Middle Dose + Tirzepatide: 11% weight loss; PL7737 High Dose + Tirzepatide: 15% weight loss....IND submission planned for 4Q2025....'We are also evaluating PL7737 as a treatment for hypothalamic obesity and plan to begin a Phase 1 single- and multiple-ascending dose (SAD/MAD) clinical trial in late 2025, with data expected in the first half of 2026'."

IND • New P1 trial • Preclinical • Obesity

Palatin's Oral MC4R Agonist PL7737 Receives FDA Orphan Drug Designation for Obesity Due to Leptin Receptor Deficiency (PRNewswire) - "IND submission planned for 4Q25...Palatin Technologies, Inc...announced the US Food & Drug Administration (FDA) has granted 'orphan drug' designation to PL7737, an oral treatment that activates the melanocortin-4 receptor, for leptin receptor (LEPR) deficiency, including obesity caused by this condition...'We are also exploring PL7737 for hypothalamic obesity and plan to begin a Phase 1 SAD/MAD study in late 2025.'"

IND • New P1 trial • Orphan drug • Obesity