Drugs / TPST-1120
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03829436 | Mar 2019 → Sep 2022 | cholangiocarcinoma, colorectal cancer, gastroesophageal cancer, head and neck squamous cell carcinoma +8 | Tempest Therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04524871 | Nov 2020 → Jul 2027 expected | liver cancer | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06680258 | Dec 2025 → Dec 2028 expected | hepatocellular carcinoma | Tempest Therapeutics | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-06-30 | Tempest Therapeutics | Regulatory Tempest Receives Clearance to Proceed with Pivotal Trial of Amezalpat Combination Therapy for First-Line HCC in China tempesttx.com ↗
It is rewarding that the regulatory officials in China see the promise and potential of amezalpat and have provided the green light to begin a registration-directed trial. |
| 2025-06-05 | Tempest Therapeutics | Regulatory Tempest Receives Orphan Drug Designation from the European Medicines Agency for Amezalpat for the Treatment of Patients with HCC tempesttx.com ↗ |
| 2025-02-10 | Tempest Therapeutics | Regulatory Tempest Granted Fast Track Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma tempesttx.com ↗
“We are thrilled to receive Fast Track designation from the FDA,” said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. |
| 2025-01-06 | Tempest Therapeutics | Regulatory Tempest Receives Orphan Drug Designation from the U.S. Food and Drug Administration for Amezalpat to Treat Patients with Hepatocellular Carcinoma (HCC) tempesttx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120) |
| 2024-11-12 | Tempest Therapeutics | Regulatory Tempest Receives FDA Study May Proceed for Pivotal Phase 3 Trial of Amezalpat Combination Therapy for the Treatment of First-Line Hepatocellular Carcinoma tempesttx.com ↗
Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class i targeted and immune-mediated therapeutics to fight cancer, today announced that the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab, the current standard of care, versus the standard of care alone in a pivotal randomized Phase 3 trial for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). |
| 2024-08-08 | Tempest Therapeutics | Results Tempest Reports Second Quarter 2024 Financial Results and Provides Business Update tempesttx.com ↗
This remarkable six-month improvement in survival compared to the standard of care, and maintenance of a strong hazard ratio, gives us confidence in the potential success of the program. |
| 2024-06-20 | Tempest Therapeutics | Results Tempest Unveils New Survival Data for Amezalpat (TPST-1120) in Randomized First-Line HCC Study Demonstrating a Six-Month Improvement over Control Arm tempesttx.com ↗ |
| 2024-04-09 | Tempest Therapeutics | Results Tempest Reports New Preclinical Data for TPST-1120 in RCC at the AACR Annual Meeting tempesttx.com ↗
In preclinical models of renal cell carcinoma (RCC), treatment with TPST-1120 reduced tumor growth by 52%-56% as monotherapy. |
| 2024-04-04 | Tempest Therapeutics | Results Tempest Announces Publication of Positive Data from Phase 1 Trial of TPST-1120 in Patients with Advanced Solid Tumors in Journal of Cancer Research Communications tempesttx.com ↗
The data showed that TPST-1120 demonstrated clinical activity, including tumor shrinkage, even in PD-1 inhibitor refractory and immune compromised cancers, and was well tolerated both as monotherapy and in combination with nivolumab. |
| 2024-03-12 | Tempest Therapeutics | Results Tempest Presents New Data at the SITC 2024 Spring Scientific Meeting Supporting Potent Anti-tumor Activity of TPST-1120 in Multiple Cancer Types tempesttx.com ↗
In preclinical models of liver, colon and pancreatic cancer, TPST-1120 elicited a greater than 50% inhibition of tumor growth with enhanced inhibition observed in liver and colon cancer models when co-administered with anti-PD-1 |
| 2023-10-11 | Tempest Therapeutics | Results Tempest Releases New Data Demonstrating Superiority of TPST-1120 Arm Across Multiple Study Endpoints in Randomized First-Line HCC Study tempesttx.com ↗
Results show a favorable PFS and OS hazard ratio for TPST-1120 arm versus atezolizumab + bevacizumab control arm |
| 2023-04-28 | Tempest Therapeutics | Results Tempest Announces Positive Early Results from Global Randomized Phase 1b/2 Combination Study of TPST-1120 in First-Line Hepatocellular Carcinoma tempesttx.com ↗
The addition of TPST-1120 resulted in a clinically-meaningful improvement in both confirmed and unconfirmed RECIST responses |
| 2023-04-17 | Tempest Therapeutics | Results Tempest Announces New Translational and Preclinical Data Presented at the 2023 AACR Annual Meeting tempesttx.com ↗
In addition, distinct on-target changes in both lipid profile and NF-κB pathway regulated immune response gene signatures were observed in patients who achieved a RECIST response, compared with non-responders, following treatment with TPST-1120 and nivolumab. |
| 2023-03-15 | Tempest Therapeutics | Results Tempest to Present Biomarker Data for TPST-1120 at the Society for Immunotherapy of Cancer (SITC) 2023 Spring Scientific Meeting tempesttx.com ↗
The poster highlights biomarker data from the Phase 1 trial of TPST-1120, an oral selective PPAR⍺ antagonist, showing an association between observed clinical benefit and fatty acid oxidation perturbations and gene expression. |
| 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 ↗
The biomarker results presented from the TPST-1120 Phase 1 clinical study demonstrate pharmacodynamic changes in circulating blood in patients who received clinical benefit from therapy that are consistent with blocking the activity of PPAR-α. |
| 2022-06-09 | Tempest Therapeutics | Results Tempest Provides ASCO KOL Feedback on TPST-1120 Clinical Results and Updated Financial Guidance tempesttx.com ↗
TPST-1120 demonstrated monotherapy clinical benefit in patients with late-line advanced, poor-prognosis cancers where responses would be unexpected |
| 2022-05-26 | Tempest Therapeutics | Results Tempest Reports Positive TPST-1120 Clinical Data from Phase 1 Trial in Patients with Advanced Solid Tumors at 2022 ASCO Annual Meeting tempesttx.com ↗
Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing therapies that combine both targeted and immune-mediated mechanisms, today announced positive results from its Phase 1 clinical trial of TPST-1120, a first-in-class 1 PPARα antagonist, as a single agent and in combination with nivolumab in patients with advanced solid tumors. |
All press releases naming this drug 26 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TPST-1120 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06680258 ↗ |
| Action | Inhibit | “TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha)” NCT03829436 ↗ |
| Modality | Small molecule | “TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha)” NCT03829436 ↗ |
| Route | Oral | “TPST-1120 administered orally” NCT03829436 ↗ |
| Target | PPARA | “TPST-1120, a small molecule selective antagonist of PPARα (peroxisome proliferator activated receptor alpha)” NCT03829436 ↗ |