Drugs / sirpiglenastat

Trials 4

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07430202 Oct 2026 → Oct 2030 expected fibrolamellar hepatocellular carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06027086 Feb 2024 → Sep 2028 expected fibrolamellar hepatocellular carcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 1/2 NCT04471415 Aug 2020 → Mar 2023 non-small cell lung carcinoma Dracen Pharmaceuticals, Inc. Terminated No outcome recorded Stop: Enrollment
Phase 21 trial
Phase 2 NCT07249372 Jan 2026 → Oct 2027 expected non-small cell lung carcinoma NYU Langone Health Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2021-06-02 Dracen Pharmaceuticals, Inc. Results Dracen Announces DRP-104 (sirpiglenastat) Presentation at ASCO 2021 Virtual Annual Meeting dracenpharma.com ↗
The pharmacokinetic and clinical safety profiles from the dose-escalation portion of this ongoing study are similar to what we observed in our comprehensive preclinical program.
2021-04-12 Dracen Pharmaceuticals, Inc. Results Dracen Announces DRP-104 (sirpiglenastat) Presentations at AACR Virtual Annual Meeting dracenpharma.com ↗
Additionally, DRP-104 has demonstrated therapeutic synergy with various immune checkpoint inhibitors, including anti-PD-1/PD-L1, anti-CTLA-4 and anti-TIGIT.
2020-10-28 Dracen Pharmaceuticals, Inc. Regulatory Dracen Pharmaceutical’s DRP-104 Granted U.S. FDA Fast Track Designation for the treatment of Non-Small Cell Lung Cancer dracenpharma.com ↗
2020-07-07 Dracen Pharmaceuticals, Inc. Results Dracen announces two DRP-104 presentations at AACR dracenpharma.com ↗
Additionally, DRP-104 has demonstrated potent and broad antitumor activity in both murine and patient derived lung adenocarcinoma and squamous tumor models with KEAP1 mutations.
2019-11-08 Dracen Pharmaceuticals, Inc. Results Dracen Pharmaceuticals announces DRP-104 presentations at the 2019 Society of Immunotherapy of Cancer (SITC) Meeting dracenpharma.com ↗
Additionally, our preclinical data demonstrate that DRP-104 combines well with immune checkpoint inhibitors leading to significant improvement in survival.

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as sirpiglenastat “In addition, we observed a profound decrease in tumor growth in several in vivo models using sirpiglenastat (DRP-104), a pro-drug version of DON that was designed to circumvent...” PMID 37814010 ↗ Oct 2023
Known as DRP-104 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07430202 ↗
3

NCT07249372 ↗

NCT04471415 ↗

NCT06027086 ↗

Action Inhibit “DRP-104, a Glutamine Antagonist” NCT04471415 ↗
Modality Small molecule — CHEMBL4650367 ↗
Route Intravenous “DRP-104 administered intravenously over 1 hour” NCT04471415 ↗