Drugs / AP-325

Trials 2

202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT05160272 Jan 2022 → Dec 2024 type 2 diabetes mellitus The Deutsche Diabetes Forschungsgesellschaft e.V. Completed No outcome recorded
Phase 2 NCT04429919 Jun 2020 → Oct 2024 neuropathy, painful Algiax Pharmaceuticals GmbH Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2025-02-04 Algiax Pharmaceuticals GmbH Results Algiax Announces Positive Data from Phase 2a Proof of Concept Study Evaluating AP-325 in Patients with Neuropathic Pain algiax.com ↗
Algiax Pharmaceuticals, a clinical-stage biotech company focused on developing innovative treatments for chronic neuropathic pain, today announced compelling topline data from its Phase 2a clinical trial evaluating AP-325 for the treatment of neuropathic pain.
2023-05-30 Algiax Pharmaceuticals GmbH Results Algiax Pharmaceuticals Announces Positive Interim Analysis of Phase 2a Study with Lead Candidate AP-325 in Chronic Neuropathic Pain algiax.com ↗
As part of a planned mid-enrollment interim analysis, the independent Data Monitoring Committee (DMC) recommended the continuation of the study and confirmed the absence of safety issues among the study participants.
2019-12-09 Algiax Pharmaceuticals GmbH Regulatory Algiax Is Ready to Go Into Proof-of-Concept for AP-325 and Welcomes New Investors algiax.com ↗
The company further announced that it has filed a clinical trial application for its phase IIa clinical trial “CURE” in the EU and plans to start patient recruitment in beginning of 2020.
2016-10-13 Algiax Pharmaceuticals GmbH Regulatory Clinical Phase Ib, Pharmacodynamic effect study algiax.com ↗
On December 10th 2015 Algiax got its approval from the German authorities (BfArM) to start the Phase Ib study entitled “Pharmacodynamic Effects of AP-325 in Healthy Male Subjects using the Intradermal (ID) Capsaicin and Pressure Pain Models”.
2016-10-13 Algiax Pharmaceuticals GmbH Results Algiax announces positive data of Clinical Phase I algiax.com ↗
In the two clinical studies AP-325 was shown to be safe and well tolerated and the aimed exposure levels with the oral formulation have been reached.

All press releases naming this drug 9 releases

DateIssuerRelease

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as AP-325 ClinicalTrials.gov intervention name — accepted as the source's own label NCT05160272 ↗
1

NCT04429919 ↗

Route Oral “AP-325 100 mg (4 x 25 mg capsules) or Placebo (4 capsules) will be orally taken once daily in the morning before meals.” NCT04429919 ↗