Drugs / Zotiraciclib

Trials 8

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT03904628 Mar 2019 → Aug 2020 malignant glioma Lee's Pharmaceutical Limited Unknown No outcome recorded
Phase 1 NCT03738111 Dec 2018 → Aug 2021 hepatocellular carcinoma Lee's Pharmaceutical Limited Withdrawn No outcome recorded
Phase 1 NCT03224104 Jun 2018 → May 2022 anaplastic astrocytoma, glioblastoma European Organisation for Research and Treatment of Cancer - EORTC Completed No outcome recorded
Phase 1 NCT02933944 Sep 2016 → Feb 2019 rectal cancer Targovax ASA Terminated No outcome recorded
Phase 1 NCT01699152 Sep 2012 → Jul 2015 chronic lymphocytic leukemia/small lymphocytic lymphoma Tragara Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1 NCT01204164 Aug 2010 → Mar 2016 acute myeloid leukemia, blast phase chronic myelogenous leukemia, BCR-ABL1 positive, myelodysplastic syndrome, plasma cell myeloma Tragara Pharmaceuticals, Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05588141 May 2023 → Aug 2028 expected brain neoplasm, cancer National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1/2 NCT02942264 Dec 2016 → Aug 2020 astrocytoma (excluding glioblastoma), gliosarcoma National Cancer Institute (NCI) Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2025-11-26 Cothera Bioscience, Inc Regulatory FDA Grants Fast Track Designation to Cothera Bioscience’s Zotiraciclib for Treatment of Recurrent High-Grade Glioma with IDH1/2 Mutations cotherabio.com ↗
Cothera Bioscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to zotiraciclib (ZTR/TG02) for the treatment of patients with recurrent high-grade gliomas (rHGG) harboring IDH1 or IDH2 mutations (IDHmut rHGG).
2017-12-18 Targovax Oy Results Targovax announces that TG02 has passed the initial safety review in the first-in-man clinical trial in colorectal cancer circio.com ↗
No issues were reported, and it has been recommended that the trial should continue.
2016-06-02 Targovax Oy Regulatory Targovax receives approval in Australia to conduct a clinical trial with TG02 – an immunotheraphy treatment targeting RAS mutations circio.com ↗
Targovax receives approval to conduct a study with TG02 and pembrolizumab, a checkpoint inhibitor, in patients with locally recurrent RAS mutated rectal cancer.

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 10 sources stand behind the page.

FieldValueCited text
Known as Zotiraciclib ClinicalTrials.gov intervention name — accepted as the source's own label NCT05588141 ↗
1

NCT02942264 ↗

Known as EX45 ChEMBL registry synonym — accepted as the source's own label CHEMBL1944698 ↗
Known as SB-1317 ChEMBL registry synonym — accepted as the source's own label CHEMBL1944698 ↗
Known as Sb-1317 free base ChEMBL registry synonym — accepted as the source's own label CHEMBL1944698 ↗
Known as TG02 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02933944 ↗
5

NCT03904628 ↗

NCT01204164 ↗

NCT03738111 ↗

NCT01699152 ↗

NCT03224104 ↗

Known as TG02 Citrate “Study of TG02 Citrate in Patients With Advanced Hepatocellular Carcinoma” NCT03738111 ↗
Known as ZOTIRACICLIB CITRATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1944698 ↗
Known as ZTR “Here, by conducting a high-throughput drug screen, we pinpointed a specific vulnerability of IDH-mutant gliomas to zotiraciclib (ZTR).” PMID 40241769 ↗ Mar 2025
Action Inhibit “Zotiraciclib (TG02) is a pyrimidine-based multi-kinase inhibitor that has been shown to have inhibitory effects on cyclin-dependent kinases (CDKs), Janus Kinase 2 (JAK2) and...” NCT02942264 ↗
5

“Tyrosine-protein kinase receptor FLT3 inhibitor” CHEMBL1944698 ↗

“Tyrosine-protein kinase JAK2 inhibitor” CHEMBL1944698 ↗

“Cyclin-dependent kinase 2 inhibitor” CHEMBL1944698 ↗

“Cyclin-dependent kinase 1 inhibitor” CHEMBL1944698 ↗

“Cyclin-dependent kinase 7 inhibitor” CHEMBL1944698 ↗

Modality Small molecule — CHEMBL1944698 ↗
Route Oral “TG02 citrate capsules given orally.” NCT01204164 ↗
Target CDK1 “Cyclin-dependent kinase 1 inhibitor” CHEMBL1944698 ↗
Target CDK2 “Cyclin-dependent kinase 2 inhibitor” CHEMBL1944698 ↗
Target CDK7 “Cyclin-dependent kinase 7 inhibitor” CHEMBL1944698 ↗
Target CDK9 “Zotiraciclib (TG02) down-regulates cyclin-dependent kinase 9 (CDK9) activity” NCT02942264 ↗
Target FLT3 “Tyrosine-protein kinase receptor FLT3 inhibitor” CHEMBL1944698 ↗
Target JAK2 “Tyrosine-protein kinase JAK2 inhibitor” CHEMBL1944698 ↗