NCT05466890 (PL8177-205) is a Phase 2 clinical trial of PL8177 in Ulcerative Colitis, sponsored by Palatin Technologies, Inc.

Who is sponsoring NCT05466890?

NCT05466890 is sponsored by Palatin Technologies, Inc.

What drugs are being tested in NCT05466890?

Interventions in NCT05466890: PL8177 Placebo, PL8177.

What condition does NCT05466890 study?

NCT05466890 studies Ulcerative Colitis, Ulcerative Colitis Acute, Ulcerative, Ulcerative Colitis Flare.

Is NCT05466890 still recruiting?

NCT05466890 is currently active, enrolled. Last updated 5 March 2025.

Last reviewed 2025-03-05 · How we verify

NCT05466890: PL8177-205

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC)

Active, enrolled Phase 2 Last updated 5 March 2025

What this trial tests

Phase 2 trial testing PL8177 Placebo in Ulcerative Colitis in 16 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 September 2022

Primary endpoint
10 February 2025

31 March 2025

Quick facts

Lead sponsor	Palatin Technologies, Inc
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	16
Start date	15 September 2022
Primary completion	10 February 2025
Estimated completion	31 March 2025
Sites	14 locations across United States

Drugs / interventions tested

PL8177 Placebo — full drug profile →
PL8177

Conditions studied

Ulcerative Colitis — all drugs for Ulcerative Colitis →
Ulcerative Colitis Acute — all drugs for Ulcerative Colitis Acute →
Ulcerative — all drugs for Ulcerative →
Ulcerative Colitis Flare — all drugs for Ulcerative Colitis Flare →

Sponsor

Palatin Technologies, Inc — full company profile →

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis or Ulcerative Colitis Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to compare PL8177 (a melanocortin receptor agonist) to placebo (in a 3:1 ratio-meaning that for every 3 people that get the active drug, one will receive placebo). The study treatment will be for 8 weeks. The study will measure safety and the body's ability to handle PL8177 and look at the improvement and healing of the intestine after 8 weeks of treatment. The study will include adult males and nonpregnant, nonlactating females with acute Ulcerative Colitis (UC).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Cyclic Peptides in Pipeline: What Future for These Great Molecules?
Costa L, Sousa E, Fernandes C. · · 2023 · cited 50× · PMID 37513908 · DOI 10.3390/ph16070996
The Melanocortin System in Inflammatory Bowel Diseases: Insights into Its Mechanisms and Therapeutic Potentials.
Gravina AG, Pellegrino R, Durante T, Palladino G, et al · · 2023 · cited 29× · PMID 37508552 · DOI 10.3390/cells12141889
Paradigm Shift in Inflammatory Bowel Disease Management: Precision Medicine, Artificial Intelligence, and Emerging Therapies.
Caballero Mateos AM, Cañadas de la Fuente GA, Gros B. · · 2025 · cited 7× · PMID 40095460 · DOI 10.3390/jcm14051536
Advancing therapeutic frontiers: a pipeline of novel drugs for UC management.
Bertin L, Massano A, Redavid C, Scarpa M, et al · · 2026 · PMID 41822012 · DOI 10.3389/fgstr.2026.1747118

Verify or expand the search:

Other recruiting trials for Ulcerative Colitis

Currently open trials in the same condition.

NCT07185009 — A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Acti · Phase 3 · recruiting
NCT07265570 — Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA) · Phase 2 · recruiting
NCT07223424 — Patient Preference for Subcutaneous vs. Intravenous Immune Therapy · Phase 2 · recruiting
NCT06405087 — A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD · Phase 3 · recruiting
NCT07184996 — An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Activ · Phase 3 · recruiting

Other Palatin Technologies, Inc trials

Trials by the same sponsor.

NCT06565611 — A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity · Phase 2 · active not recruiting
NCT05709444 — A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease · Phase 2 · completed
NCT05201170 — A Phase 3, Multi-Center Study Evaluating PL9643 in Patients with Dry Eye · Phase 3 · completed
NCT04318145 — Study to Evaluate Sex Differences in the Acute Effects of PL-3994 in Heart Failure Subjects · Phase 2 · terminated
NCT01304628 — Cross-Over Study of Subcutaneous Study Drug for the Treatment of Patients With Mild to Moderate Asthma · Phase 2 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05466890 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Palatin Technologies, Inc
Last refreshed: 5 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05466890.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing