Drugs / PL9643
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT05201170 | Dec 2021 → Sep 2023 | dry eye syndrome | Palatin Technologies, Inc | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT04268069 Comparator | Feb → Oct 2020 | dry eye syndrome | ORA, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-05-08 | Palatin Technologies, Inc | Results Palatin Presents Breakthrough Symptom Resolution Data from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease at ARVO 2025 palatin.com ↗ |
| 2025-04-29 | Palatin Technologies, Inc | Results Palatin Announces Breakthrough Symptom Resolution in Updated Analyses from Phase 3 PL9643 MELODY-1 Clinical Trial in Dry Eye Disease palatin.com ↗ |
| 2024-10-24 | Palatin Technologies, Inc | Results Inflammatory Disease Healing Data via Palatin’s Novel Melanocortin Receptor Agonists Presented at the 19th Annual Peptide Therapeutics Symposium palatin.com ↗
PL9643 ophthalmic solution demonstrated effectiveness with statistical significance across multiple clinical signs and reduced symptomatic ocular pain in the Phase 3 MELODY-1 clinical trial. |
| 2024-08-28 | Palatin Technologies, Inc | Regulatory FDA Confirms Acceptability of Palatin’s Remaining Phase 3 Pivotal Clinical Trials for PL9643 in Dry Eye Disease (DED) palatin.com ↗ |
| 2024-04-08 | Palatin Technologies, Inc | Results Palatin Announces Phase 3 PL9643 MELODY-1 Dry Eye Disease (DED) Clinical Data Results Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2024 palatin.com ↗ |
| 2024-02-28 | Palatin Technologies, Inc | Results Palatin Announces Results of PL9643 MELODY-1 Pivotal Phase 3 Clinical Trial in Patients with Dry Eye Disease (DED) palatin.com ↗
Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today announced results for its PL9643 MELODY-1 pivotal Phase 3 clinical trial evaluating the safety and efficacy of PL9643 versus vehicle in the treatment of dry eye disease (DED). |
| 2023-05-08 | Palatin Technologies, Inc | Results Palatin Invites Investors to Listen to Replay of the PL9643 Dry Eye Disease Key Opinion Leader Webinar palatin.com ↗
The data highlighted the excellent ocular tolerability of PL9643 eye drops and the broad efficacy on the signs and symptoms of dry eye disease. |
| 2023-04-27 | Palatin Technologies, Inc | Results Palatin Presents Initial Dry Eye Disease Phase 3 Clinical Data at the Association of Research in Vision and Ophthalmology 2023 Annual Conference palatin.com ↗
The excellent ocular tolerability and efficacy across multiple signs and symptoms of DED distinguishes PL9643 from currently approved treatments for DED. |
| 2022-08-16 | Palatin Technologies, Inc | Results Palatin Reports Positive Interim Analysis in Phase 3 Pivotal Study of PL9643 in Patients with Dry Eye Disease palatin.com ↗ |
| 2021-02-17 | Palatin Technologies, Inc | Results Palatin Technologies, Inc. Reports Second Quarter Fiscal Year 2021 Financial Results and Recent Business Highlights palatin.com ↗
Statistical significance for the primary endpoints was not reached in the overall enrolled population that included mild, moderate, and severe patients, as measured at the 12-week primary evaluation visit. |
| 2021-02-10 | Palatin Technologies, Inc | Regulatory Palatin Technologies Announces Filing of International Patent Application Claiming PL9643 palatin.com ↗
today announced the filing of an international patent application under the Patent Cooperation Treaty (PCT) directed to the composition of PL9643 and a related family of melanocortin agonist peptides. |
| 2020-12-15 | Palatin Technologies, Inc | Results Palatin Technologies Announces Positive Results From its Phase 2 Study of PL9643 in Patients With Dry Eye Disease palatin.com ↗
Palatin Technologies, Inc. (NYSE American: PTN), a specialized biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor systems, today announced positive results in its Phase 2 study of PL9643 for the treatment of dry eye disease (DED). |
All press releases naming this drug 19 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PL9643 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04268069 ↗ |
| Action | Activate | “The melanocortin receptor pan-agonist PL9643, a potential therapy for ocular diseases, was investigated in a phase 2, 12-week study in patients with dry eye disease (DED).” PMID 37677000 ↗ Sep 2023 |
| Route | Topical | “PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.” NCT04268069 ↗ |