Kura Oncology
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2014-01-01
- Employees
- 142
- Market Cap
- $1.5B
- Website
- http://www.kuraoncology.com
- Introduction
Kura Oncology, Inc. operates as a clinical-stage biopharmaceutical company, which engages in the research and development of medicines for the treatment of cancer. Its pipeline includes Tipifarnib, which is a Farnesyl transferase inhibitor for HRAS Mutant Solid Tumors, Chronic Myelomonocytic Leukemia, KO-947, which is an ERK inhibitor for MAPK Pathway Tumors, and KO-539, which is a Menin MLL inhibitor for acute leukemias. The company was founded by Troy E. Wilson, Yi Liu, Pingda Ren and Antonio Gualberto on August 22, 2014 and is headquartered in San Diego, CA.
Clinical Trials
35
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (33 trials with phase data)• Click on a phase to view related trials
Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- First Posted Date
- 2025-06-05
- Last Posted Date
- 2025-10-22
- Lead Sponsor
- Kura Oncology, Inc.
- Target Recruit Count
- 1300
- Registration Number
- NCT07007312
- Locations
- 🇺🇸
Yale University School of Medicine, New Haven, Connecticut, United States
🇺🇸Wayne State University School of Medicine, Detroit, Michigan, United States
A Study of Ziftomenib, an Oral Menin Inhibitor, in Combination With Imatinib in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
- Conditions
- Gastrointestinal Stromal Tumor (GIST)Gastrointestinal Stromal Tumor (GIST) of the Gastrointestinal TractGastrointestinal Stromal CancerGastrointestinal Stromal NeoplasmGastrointestinal Stromal Tumor, MalignantGastrointestinal Stromal Cell Tumors
- Interventions
- First Posted Date
- 2024-10-23
- Last Posted Date
- 2025-11-05
- Lead Sponsor
- Kura Oncology, Inc.
- Target Recruit Count
- 157
- Registration Number
- NCT06655246
- Locations
- 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Thomas Jefferson University, Philadelphia, Pennsylvania, United States
🇺🇸Mayo Clinic Cancer Center, Rochester, Minnesota, United States
KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
- Conditions
- Solid Tumors With HRAS AlterationsNon Small Cell Lung Cancer (NSCLC)Colorectal Cancer (CRC)Pancreatic Ductal Adenocarcinoma (PDAC)Clear Cell Renal Cell Carcinoma (ccRCC)Renal Cell Carcinoma (Kidney Cancer)
- Interventions
- First Posted Date
- 2023-09-07
- Last Posted Date
- 2025-10-10
- Lead Sponsor
- Kura Oncology, Inc.
- Target Recruit Count
- 270
- Registration Number
- NCT06026410
- Locations
- 🇮🇹
Istituto Nazionale Tumori IRCCS, Napoli, Italy
🇮🇹Camplus Humanitas University, Rozzano, Italy
🇺🇸Mayo Clinic Comprehensive Cancer Center, Rochester, Minnesota, United States
Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
- Conditions
- AMLAML With Mutated NPM1Hematologic MalignancyKMT2ArNPM1 MutationMLL RearrangementLeukemiaAcute Myeloid LeukemiaLeukemia, MyeloidLeukemia, Myeloid, Acute
- Interventions
- Biological: Granulocyte colony-stimulating factor
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2025-11-10
- Lead Sponsor
- Kura Oncology Inc.
- Target Recruit Count
- 30
- Registration Number
- 2023-510288-37-00
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
🇺🇸USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
Expanded Access to Ziftomenib
- Conditions
- Acute Lymphoblastic Leukemia, With Appropriate MutationsAcute Myeloid Leukemia, With NPM1 Mutations
- First Posted Date
- 2023-02-22
- Last Posted Date
- 2025-06-04
- Lead Sponsor
- Kura Oncology, Inc.
- Registration Number
- NCT05738538
- Prev
- 1
- 2
- 3
- 4
- Next
News
FDA Approves Kura Oncology's Komzifti for NPM1-Mutated AML with Competitive Safety Advantage
The FDA approved Kura Oncology's once-daily pill Komzifti (ziftomenib) for treating relapsed/refractory acute myeloid leukemia with NPM1 mutations, affecting about 30% of AML cases.
Five Major FDA Decisions Expected in November 2025 Across Cancer, Rare Disease, and Genetic Disorders
The FDA is set to make five significant regulatory decisions in November 2025, including approvals for treatments targeting rare genetic disorders, multiple cancer types, and kidney disease.
Kura Oncology Showcases Preclinical Data for Next-Generation FTI KO-2806 in Combination Therapies
Kura Oncology presented preclinical data demonstrating KO-2806's potential to overcome drug resistance when combined with PI3Kα inhibitors, KRAS inhibitors, and antiangiogenic TKIs across multiple tumor types.
Charm Therapeutics Raises $80M to Advance AI-Designed Menin Inhibitor for AML Treatment
UK-based Charm Therapeutics secured $80 million in Series B funding to advance its next-generation menin inhibitor for acute myeloid leukemia into Phase I clinical trials starting Q1 2026.
Kura Oncology's Ziftomenib Receives FDA Priority Review for NPM1-Mutant AML, PDUFA Date Set for November 2025
Kura Oncology's lead asset ziftomenib has advanced to FDA Priority Review for relapsed/refractory NPM1-mutant acute myeloid leukemia, with a PDUFA date of November 30, 2025.
Day One Biopharmaceuticals Appoints Michael Vasconcelles as Head of R&D to Drive Pipeline Expansion
Day One Biopharmaceuticals has appointed Michael Vasconcelles, M.D., as Head of Research and Development, bringing over 25 years of oncology research and development expertise to the company.
FDA Accepts Kura Oncology's NDA for Ziftomenib in NPM1-Mutant AML with Priority Review
The FDA has accepted Kura Oncology's new drug application for ziftomenib, an oral menin inhibitor for treating relapsed or refractory acute myeloid leukemia with NPM1 mutations.
Pharmaceutical Industry Sees Wave of Board Appointments as Companies Strengthen Leadership
Pharmaceutical and biotech companies across Europe and North America have made significant board appointments, bringing industry veterans and scientific experts to strengthen their leadership teams.
Kura Oncology Initiates Phase 1 Trial Combining Ziftomenib with Imatinib for Advanced GIST Treatment
Kura Oncology has dosed first patients in KOMET-015, a Phase 1 trial evaluating ziftomenib in combination with imatinib for advanced gastrointestinal stromal tumors (GIST) after imatinib failure.
Kura Oncology's KO-2806 Shows Promise in Combination Therapy for Renal Cell Carcinoma
Preclinical data for Kura Oncology's next-generation farnesyl transferase inhibitor KO-2806 in combination with cabozantinib has been selected for oral presentation at the 2025 AACR Annual Meeting.