Drugs / Darleukin
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT07566897 | May 2026 → Dec 2029 expected | clear cell renal carcinoma, colorectal adenocarcinoma, pancreatic adenocarcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06640413 | Oct 2025 → May 2028 expected | — | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 1 | NCT02086721 | Dec 2015 → May 2017 | cancer | Maastricht Radiation Oncology | Completed | No outcome recorded |
| Phase 1 | NCT01198522 | Jun 2007 → Nov 2014 | — | Philogen S.p.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02957019 | Jul 2013 → Sep 2023 | diffuse large B-cell lymphoma | Philogen S.p.A. | Terminated | No outcome recorded |
| Phase 1/2 | NCT02076646 | Jul 2013 → May 2016 | metastatic melanoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 1/2 | NCT01058538 | Nov 2005 → Apr 2008 | cancer | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 211 trials | ||||||
| Phase 2 | NCT07227350 | Jun 2026 → Feb 2031 expected | skin basal cell carcinoma | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT07228442 | Feb 2026 → Feb 2031 expected | skin squamous cell carcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07227870 | Feb 2026 → Feb 2031 expected | skin basal cell carcinoma | Philogen S.p.A. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06284590 | Jul 2024 → Jul 2028 expected | melanoma | Philogen S.p.A. | Recruiting | No outcome recorded |
| Phase 2 | NCT05329792 | Mar 2023 → Jun 2024 | Kaposi's sarcoma, cutaneous neuroendocrine carcinoma, keratoacanthoma, primary cutaneous T-cell lymphoma +3 | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 2 | NCT04362722 | Sep 2020 → Sep 2024 | basal cell carcinoma, skin squamous cell carcinoma | Philogen S.p.A. | Unknown | No outcome recorded |
| Phase 2 | NCT03705403 | Apr 2019 → Jan 2025 | metastatic neoplasm, non-small cell lung carcinoma | Maastricht University Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT02735850 | Dec 2015 → Feb 2021 | non-small cell lung carcinoma | Maastricht Radiation Oncology | Withdrawn | No outcome recorded |
| Phase 2 | NCT02076633 | Dec 2012 → May 2015 | cutaneous melanoma | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01253096 | Apr 2010 → Sep 2013 | melanoma | Philogen S.p.A. | Completed | No outcome recorded |
| Phase 2 | NCT01055522 | Jun 2008 → Feb 2013 | metastatic melanoma | Philogen S.p.A. | Terminated | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT02938299 | Jul 2016 → Oct 2024 overdue | melanoma | Philogen S.p.A. | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2025-06-24 | Philogen S.p.A. | Regulatory Philogen Provides Update on Marketing Authorization Application for Nidlegy™ in the European Union philogen.com ↗
After careful consideration of the feedback and ongoing dialogue with EMA, we have decided to withdraw the MAA for Nidlegy™ and resubmit an updated application, in view of the potential of the product in melanoma and beyond. |
| 2025-06-24 | Sun Pharmaceutical Industries, Inc. | Regulatory Philogen Provides Update on Marketing Authorization Application for Nidlegy™ in the European Union sunpharma.com ↗ |
| 2024-07-04 | Philogen S.p.A. | Regulatory Submission of NidlegyTM Marketing Authorization Application Validated by EMA philogen.com ↗
The first marketing authorization application of Nidlegy™ for the treatment of locally advanced fully resectable melanoma was submitted on June 3rd and validated by EMA on June 20 |
| 2024-06-04 | Philogen S.p.A. | Regulatory Richiesta di autorizzazione all’immissione in commercio per il prodotto Nidlegy™ sottomessa all’EMA philogen.com ↗
sono liete di annunciare la sottomissione di una richiesta di autorizzazione all'immissione in commercio (AIC) all'Agenzia Europea per i Medicinali (EMA) per l'approvazione del prodotto Nidlegy™ |
| 2024-06-04 | Philogen S.p.A. | Regulatory Nidlegy™ Marketing Authorization Application Submitted to EMA philogen.com ↗
Nidlegy™ Marketing Authorization Application Submitted to EMA |
| 2024-06-04 | Sun Pharmaceutical Industries, Inc. | Regulatory Press Release Nidlegy™ Marketing Authorization Application Submitted to EMA sunpharma.com ↗
Nidlegy™ Marketing Authorization Application Submitted to EMA |
| 2023-10-16 | Philogen S.p.A. | Results Nidlegy™ Phase III PIVOTAL trial meets the study’s primary objective in patients with locally advanced fully resectable melanoma (Price Sensitive) philogen.com ↗
Intratumoral Nidlegy™ followed by surgery significantly improved the Recurrence-Free Survival compared to surgery alone |
| 2022-02-17 | Philogen S.p.A. | Regulatory Philogen receives authorisation to initiate new study in France to evaluate Nidlegy™ in several non-melanoma skin cancers philogen.com ↗
France’s National Agency for the Safety of Medicines and Health Products (ANSM) has authorized the Company to run a Phase II study of Nidlegy™ in patients affected by different non - melanoma skin cancer indications. |
| 2020-06-26 | Philogen S.p.A. | Regulatory Philogen received clinical trial authorisation with NIDLEGYTM in nonmelanoma skin cancer philogen.com ↗
Philogen S.p.A., a privately -owned biotechnology company, is pleased to announce that the Swiss national competent authority Swissmedic issued the authorization to run a clinical phase II study in patients with locally-advanced, not metastatic nonmelanoma skin cancer. |
| 2020-06-24 | Philogen S.p.A. | Regulatory Philogen received combination pack approval for NidlegyTM philogen.com ↗
NidlegyTM combination pack has now received confirmation of eligibility to the centralized procedure for submission of an appli cation for a Union Marketing Authorisation under Article 3(1) - Indent 1 - Biotech medicinal product of Regulation (EC) No 726/2004. |
| 2017-10-12 | Philogen S.p.A. | Regulatory Philogen announces authorization from FDA of a pivotal registration trial in USA for the treatment of resectable melanoma philogen.com ↗
Philogen S.p.A. (www.philogen.com), a privately owned biotechnology company, today announced approval by Food and Drugs Administration (FDA) of an IND for a Phase 3 registration trial with investigational melanoma drug DAROMUN (L19IL2 + L19TNF). |
All press releases naming this drug 11 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Darleukin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03705403 ↗ |
| Known as | L19-IL2 | “L19-IL2 is an immunocytokine composed of an antibody fragment specific to the EDB domain of fibronectin, a tumor angiogenesis marker, and of human interleukin-2 (IL2).” PMID 22028492 ↗ Oct 201120“Tumor-targeting Human L19-IL2 Monoclonal Antibody-cytokine Fusion Protein” NCT02076646 ↗ “antibody-cytokine conjugate L19-IL2” NCT06640413 ↗ |
| Modality | Protein / enzyme biologic | “Tumor-Targeting Human L19IL2 Monoclonal Antibody-Cytokine Fusion Protein” NCT01055522 ↗ |
| Route | Intravenous | “Intravenous (IV) infusion of L19IL2” NCT01055522 ↗ |