Drugs / TPST-1495

Trials 3

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04344795 May 2020 → Sep 2024 colorectal cancer, endometrial cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma +3 Tempest Therapeutics Completed No outcome recorded
Phase 22 trials
Phase 2 NCT06557733 Jul 2026 → Jun 2027 classic familial adenomatous polyposis, colorectal carcinoma National Cancer Institute (NCI) Suspended No outcome recorded
Phase 2 NCT06129604 Apr 2024 → Aug 2025 overdue colorectal carcinoma, endometrial carcinoma University of Oklahoma Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2025-04-21 Tempest Therapeutics Regulatory Tempest Receives Orphan Drug Designation from the FDA for TPST-1495 to Treat Patients with FAP tempesttx.com ↗
“Receiving orphan drug designation for TPST-1495, our second clinical program, is a significant milestone in our mission to bring innovative therapies to patients with unmet medical need,”
2025-03-13 Tempest Therapeutics Regulatory FDA Study May Proceed Notice Received for Phase 2 Trial of TPST-1495 for the Treatment of Familial Adenomatous Polyposis (FAP) tempesttx.com ↗
The Phase 2 study in patients with FAP will begin this year and will be run by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (“NCI”) Division of Cancer Prevention.
2023-07-19 Tempest Therapeutics Results Tempest Announces Publication in Cancer Research Communications Highlighting the Significantly Increased Potency of TPST-1495 Against Prostaglandin-Driven Tumor Models by Blocking EP2 and EP4 Together tempesttx.com ↗
2023-05-25 Tempest Therapeutics Results Tempest to Present Phase 1 Monotherapy and Combination Data at ASCO for TPST-1495 in Patients with Advanced Cancers tempesttx.com ↗
Data show tumor shrinkage and prolonged disease control in both monotherapy and in combination with pembrolizumab
2022-11-10 Tempest Therapeutics Results Tempest Presents Data Showing TPST-1120-Induced Pharmacodynamic Changes Consistent with Clinical Benefit Observed in Patients with Cancer tempesttx.com ↗
In addition, data presented from TPST-1495 showed that its dual antagonism of EP2 and EP4 generated significantly greater immune activation in human immune cells and anticancer activity in mouse tumor models than single inhibitors of either receptor, or the COX-2 inhibitor, celecoxib.
2022-04-08 Tempest Therapeutics Results Tempest Presents Promising Preclinical Data on Two Oncology Programs at the 2022 AACR Annual Meeting tempesttx.com ↗
The first presentation reports on new preclinical data that support TPST-1495, a novel agent designed to specifically block the cancer-promoting EP2 and EP4 prostaglandin E2 (PGE2) receptors, further differentiating TPST-1495 from other approaches targeting the PGE2 pathway.
2020-01-30 Tempest Therapeutics Regulatory Tempest Therapeutics Announces FDA Clearance of Investigational New Drug Application for TPST-1495 and Welcomes New Investors tempesttx.com ↗
Tempest Therapeutics, Inc., a clinical-stage oncology company developing therapeutics that combine both precision and immune-mediated mechanisms, announced today that the U.S. Food and Drug Administration (FDA) has cleared the company's investigational new drug (IND) application for TPST-1495, a small molecule dual antagonist of the prostaglandin receptors EP2 and EP4.

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as TPST-1495 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06129604 ↗
2

NCT06557733 ↗

NCT04344795 ↗

Action Inhibit “TPST-1495, a dual antagonist targeting human prostaglandin E2 receptor subtypes EP2 and EP4” NCT06129604 ↗
Route Oral “TPST-1495 administered orally twice daily” NCT04344795 ↗