Drugs / TRE-515
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT05055609 | Sep 2021 → Dec 2026 expected | cancer | Trethera | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2026-05-06 | Trethera | Results Trethera To Present Optic Neuritis Research at Los Angeles Bioscience Ecosystem Summit 2026 trethera.com ↗
These findings highlight the potential of targeting deoxycytidine kinase (dCK) as a novel therapeutic approach for optic neuritis. |
| 2025-10-28 | Trethera | Results Trethera Successfully Completes Phase 1 Dose Escalation Trial Demonstrating Broad Therapeutic Window, Favorable Safety, and Confirmed Target Engagement trethera.com ↗
The independent Safety Review Committee unanimously concluded that no dose-limiting toxicities occurred at any dose level, including the final and highest tested dose of 1,440 mg per day. |
| 2025-07-30 | Trethera | Regulatory FDA Provides Trethera Clearance to Initiate TRE-515 Clinical Trial in Healthy Volunteers to Study Food Effect and Biomarkers trethera.com ↗
Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared a clinical trial evaluating its novel drug, TRE-515, in healthy volunteers. |
| 2025-07-09 | Trethera | Regulatory FDA Grants Fast Track Designation for TRE-515 in Combination with Radiation Therapy for the Treatment of Metastatic Castration Resistant Prostate Cancer trethera.com ↗
Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company developing first-in-class therapies for cancer and autoimmune diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its novel drug, TRE-515, in the treatment of prostate cancer. |
| 2025-03-31 | Trethera | Results Trethera Treats a Late-Stage, Heavily Pretreated Amyotrophic Lateral Sclerosis (ALS) Patient with TRE-515 trethera.com ↗
Over a three month dosing period with TRE-515, objective measures demonstrated disease stabilization, including forced vital capacity as well as the Revised ALS Functional Rating Scale (ALSFRSR). |
| 2025-02-25 | Trethera | Results Trethera and UCLA Publish Data Demonstrating TRE-515 Ability to Control Immune Cell Activation That Causes Multiple Sclerosis Symptoms in Mice trethera.com ↗
Targeting dCK with TRE-515 slowed the rate of T and B cell division, leading to fewer cells. |
| 2023-03-15 | Trethera | Results Dose Escalation Portion of Phase 1 Solid Tumors Trial Produces Favorable Results in Heavily Pretreated Solid Tumor Patients trethera.com ↗
This recommendation follows favorable results from the company’s Phase 1a dose escalation clinical trial in high risk, heavily pretreated, patients with solid tumor malignancies. |
| 2023-01-24 | Trethera | Results Trethera Announces Poster Presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Meeting trethera.com ↗
Targeting dCK with first-in-class inhibitor TRE-515 is shown to block symptoms across multiple MS mouse models by specifically limiting activated B and CD4 T cell proliferation. |
| 2023-01-16 | Trethera | Results Targeting Deoxycytidine Kinase Improves Symptoms in Mouse Models of Multiple Sclerosis trethera.com ↗
Targeting dCK with the small molecule dCK inhibitor TRE-515 limits disease severity when treatments are started at disease induction or when symptoms first appear. |
| 2022-09-07 | Trethera | Results Trethera and UCLA Publish Data Demonstrating TRE-515 Ability to Control and Improve Multiple Sclerosis Symptoms in Mouse Models trethera.com ↗
Their results demonstrated that dCK activity is necessary for the development of clinical symptoms in both EAE models of MS. |
| 2022-08-17 | Trethera | Regulatory Trethera Receives U.S. Patent Office Notice of Allowance Covering TRE-515 Structural Claims, Extending Protections to Late 2041 trethera.com ↗
Trethera Corporation (“Trethera”), a clinical stage biopharmaceutical company committed to developing novel drugs targeting nucleotide metabolism for the treatment of cancer and autoimmune diseases, announces today that the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for a composition of matter patent covering the polymorphic form of TRE-515. |
| 2022-06-01 | Trethera | Results Trethera Phase 1 Solid Tumors Trial Dose Escalates To Fourth Cohort After Safety Review Committee Determines Primary Trial Endpoint Achieved trethera.com ↗
In the trial thus far, TRE-515 demonstrated a manageable safety and tolerability profile resulting in authorization to increase the daily dose to 240 mg for the fourth cohort. |
| 2021-12-09 | Trethera | Results Safety Review Committee Advances Trethera Phase 1 Solid Tumors Trial to Next Dose After First Patient Cohort Achieves Primary Endpoint trethera.com ↗
No SAEs and no drug-related treatment-emergent adverse events were observed during the administration of TRE-515 as a monotherapy treatment. |
| 2021-11-12 | Trethera | Regulatory Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 for the Treatment of Demyelinating Optic Neuritis trethera.com ↗ |
| 2021-04-19 | Trethera | Regulatory Trethera Receives FDA Approval To Initiate TRE-515 Phase 1 Clinical Trial in Solid Tumors Monotherapy trethera.com ↗
Trethera Corporation (Trethera), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases, announced that the U.S. Food and Drug Administration (FDA) has approved its TRE-515 investigational new drug (IND) application for the treatment of solid tumor malignancies. |
| 2021-01-07 | Trethera | Regulatory Trethera Announces FDA Orphan Drug Designation Granted to TRE-515 in the Treatment of Acute Disseminated Encephalomyelitis trethera.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status (ODS) to TRE-515, Trethera’s first-in-class drug for the treatment of acute disseminated encephalomyelitis (ADEM). |
| 2020-11-02 | Trethera | Regulatory Trethera Announces U.S. Patent Application Filed for TRE-515, Extending Major Markets Exclusivity until 2041 trethera.com ↗
Trethera Corporation (“Trethera”), a biopharmaceutical company committed to developing novel drugs targeting cellular nucleotide metabolism for the treatment of cancer and autoimmune diseases is pleased to announce that it has filed a provisional patent application with the US Patent & Trademark Office for the company’s first-in-class drug TRE-515. |
All press releases naming this drug 29 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TRE-515 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05055609 ↗ |
| Action | Inhibit | “inhibitor of deoxycytidine kinase (dCK)” NCT05055609 ↗ |
| Modality | Small molecule | “first-in-class small molecule inhibitor” NCT05055609 ↗ |
| Route | Oral | “TRE-515 will be administered orally once daily” NCT05055609 ↗ |
| Target | DCK | “inhibitor of deoxycytidine kinase (dCK)” NCT05055609 ↗ |