Drugs / AUP1602-C
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04281992 | Jan 2020 → Mar 2023 | ulcer of lower limbs | Aurealis Oy | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06111183 | Jul 2023 → Nov 2025 | ulcer of lower limbs | Aurealis Oy | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-12-04 | Aurealis Oy | Results Aurealis Therapeutics Announces Positive Blinded Evaluator Efficacy Results of “DIAMEND” Phase-2 Randomized Controlled Trial: AUP-16 Tripling the Complete Wound Closure Rate in Patients with Chronic Diabetic Foot Ulcers aurealistherapeutics.com ↗ |
| 2025-04-08 | Aurealis Oy | Results Aurealis Therapeutics Concludes Largest EWMA Participation to Date with Exciting Investigator Data of DIAMEND Phase 2 DFU Clinical Trial Presented by Prof. Alberto Piaggesi aurealistherapeutics.com ↗
Representing Aurealis Therapeutics were CEO Juha Yrjänheikki, COO Laurent Décory, and CMO Haritha Samaranayake, along with distinguished Key Speaker Professor Alberto Piaggesi, who shared Aurealis’ exciting Phase 2 clinical trial investigator data results of AUP-16 – a novel multi-targeting cell and gene therapy for non-healing Diabetic Foot Ulcers (DFU). |
| 2024-11-04 | Aurealis Oy | Results Aurealis Therapeutics Announces Peer-Reviewed Paper Published from Phase 1 Study of AUP-16 for Non-Healing Diabetic Foot Ulcers aurealistherapeutics.com ↗
We are incredibly proud to share the publication of our Phase 1 study results for AUP-16 in Therapeutic Advances in Endocrinology and Metabolism , |
| 2024-02-27 | Aurealis Oy | Regulatory Aurealis Therapeutics Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support and Accelerated Assessment of AUP-16 in Non-healing Diabetic Foot Ulcers aurealistherapeutics.com ↗
Aurealis Therapeutics today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Aurealis Therapeutics’ lead product candidate AUP-16 (AUP1602-C) for the treatment of non-healing Diabetic Foot Ulcers (nhDFU). |
| 2023-11-29 | Aurealis Oy | Regulatory Aurealis Therapeutics Partner Xbiome Receives IND Approval from China’s National Medical Products Administration for the Phase 2 Study with AUP-16 in Diabetic Foot Ulcers aurealistherapeutics.com ↗
Xbiome announced that its Phase 2 study with AUP-16 (AUP1602-C) in Diabetic Foot Ulcer (DFU) has officially obtained IND approval from the National Medical Products Administration (NMPA) and the study can be initiated in China. |
| 2023-05-09 | Aurealis Oy | Regulatory Aurealis Therapeutics announces approval of multi-center, randomized, placebo-controlled diabetic foot ulcer Phase 2 study to start May 2023 in Italy, Germany and Poland. aurealistherapeutics.com ↗
We are extremely happy to announce Aurealis Therapeutics Phase 2 clinical trial to investigate the safety and efficacy of its lead clinical candidate AUP1602-C in patients with non-healing diabetic foot ulcers received regulatory approval. |
| 2018-10-15 | Aurealis Oy | Regulatory Aurealis Therapeutics submits Clinical Trial Application for AUP-16 Phase 1 DFU study aurealistherapeutics.com ↗
Aurealis Therapeutics, a private biopharmaceutical company developing novel three-in-one combination biologics for chronic non-healing wounds and cancer announced today the successful submission of its first Clinical Trial Application (CTA) to the German Health Authority Paul-Ehrlich-Institute (PEI) for the lead development candidate AUP1602-C to be studied in a first-in-human phase 1-2A clinical study as treatment of diabetic foot ulcers (DFUs). |
All press releases naming this drug 7 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AUP1602-C | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04281992 ↗ |
| Route | Topical | “AUP1602-C is topically applied on chronic wounds and covered by wound dressing.” NCT04281992 ↗ |