Product Description
GFH009 is a potent and highly selective CDK9 inhibitor. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT04588922)
Mechanisms of Action: CDK9 Inhibitor
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral, Intravenous
FDA Designation: Fast Track - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Lymphoma|Myeloid Leukemia|T-Cell Leukemia|T-Cell Lymphoma|T-Cell Peripheral LymphomaFast Track - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Myeloid LeukemiaOrphan Drug - Acute Leukemia|Acute Myeloid Leukemia|Leukemia|Lymphoma|Myeloid Leukemia|T-Cell Leukemia|T-Cell Lymphoma|T-Cell Peripheral LymphomaOrphan Drug - Acute Myeloid LeukemiaOrphan Drug - Lymphoma|T-Cell Lymphoma|T-Cell Peripheral LymphomaOrphan Drug - T-Cell Peripheral Lymphoma *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: Sellas Life Sciences Group
Company Location: Eastern America
Company Founding Year: 2012
Additional Commercial Interests: GenFleet Therapeutics (Australia)
Clinical Description
Countries in Clinic: China, Italy, Spain, United States
Active Clinical Trial Count: 4
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Sellas Life Sciences announced they will present P2 Acute Myeloid Leukemia results on 2026-12-14 for Tambiciclib
- Clinical Outcomes Expected - Sellas Life Sciences announced they will present P2 Acute Myeloid Leukemia results in 4Q26 for Tambiciclib
- Clinical Outcomes Reported - Sellas Life Sciences presented P0 Pancreatic Cancer results on 2026-09-25 for Tambiciclib
Highest Development Phases
Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell
Phase 1: Lymphoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04588922 |
GFH009X2101 | P2 |
Recruiting |
Acute Myeloid Leukemia|Lymphocytic Chronic B-Cell Leukemia|Chronic Myeloid Leukemia|Chronic Lymphoid Leukemia|Lymphoma, B-Cell|Acute Lymphoid Leukemia |
2026-12-30 |
40% |
2026-03-17 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
CTR20210356 |
CTR20210356 | P1 |
Recruiting |
Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Chronic Myeloid Leukemia|Lymphoma|Chronic Lymphoid Leukemia |
None |
2025-04-29 |
Patient Enrollment|Treatments |
|
2025-524308-31-00 |
IRST204.09 | P2 |
Not yet recruiting |
Acute Myeloid Leukemia |
2029-06-01 |
|||
NCT06375733 |
GFH009X1202 | P2 |
Recruiting |
Lymphoma, B-Cell |
2026-12-31 |
28% |
2024-04-20 |
Primary Endpoints|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
03/17/2026 |
News Article |
SELLAS Life Sciences to Present Preclinical Data Highlighting Potent Activity of SLS009 in AML at the 2026 AACR Conference |
|
03/12/2026 |
News Article |
SELLAS Life Sciences Announces Enrollment of First Patient in Newly Diagnosed First-Line AML Trial of SLS009 |
|
01/14/2026 |
News Article |
SELLAS Life Sciences Enters Agreement with IMPACT-AML to Expand SLS009 Clinical Program into Europe |
|
12/29/2025 |
News Article |
SELLAS Life Sciences Provides Update on Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) |