Product Description
Imetelstat is a first-in-class telomerase inhibitor that could change the course of blood cancers—changing lives for the better. The development of imetelstat is grounded on Nobel Prize-winning scientific discoveries by early Geron collaborators that expanded the understanding of telomeres and telomerase and their role in the proliferation of cancer cells. Using this knowledge, Geron scientists pioneered a new approach in which oligonucleotides (short single strands of synthetic DNA or RNA) inhibit the activity of telomerase, an enzyme that helps maintain telomeres and enables the continued proliferation of malignant cells. (Sourced from: https://www.geron.com/research-and-development/imetelstat/)
Mechanisms of Action: telomerase Inhibitor
Novel Mechanism: No
Modality: Nucleic Acid
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Geron
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Hungary, India, Israel, Italy, Malaysia, Netherlands, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 8
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Geron announced they will present P3 Myelodysplastic Syndrome results on 2025-12-06 for Imetelstat
- Clinical Outcomes Reported - Geron presented P1 Myelofibrosis results on 2025-05-30 for Imetelstat
- Clinical Outcomes Reported - Geron presented P1 Myelofibrosis results on 2024-12-10 for Imetelstat
Highest Development Phases
Phase 3: Myelodysplastic Syndrome|Myelofibrosis
Phase 2: Acute Myeloid Leukemia|Preleukemia
Phase 1: Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Juvenile Myelomonocytic Leukemia,
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| MYF1001 | P1 |
Recruiting |
Myelofibrosis |
2027-02-01 |
12% |
2025-05-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| PEPN2312 | P1 |
Recruiting |
Chronic Myeloid Leukemia|Acute Myeloid Leukemia|Juvenile Myelomonocytic Leukemia,|Preleukemia|Chronic Myelomonocytic Leukemia|Acute Myelomonocytic Leukemia|Acute Monocytic Leukemia|Myelodysplastic Syndrome |
2026-06-30 |
50% |
2025-02-07 |
Primary Endpoints|Treatments |
| IMpress | P2 |
Active, not recruiting |
Preleukemia|Acute Myeloid Leukemia|Myelodysplastic Syndrome |
2025-09-30 |
12% |
2025-03-18 |
Primary Completion Date|Primary Endpoints|Treatments |
| IMpress_001 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2026-06-30 |
2025-05-02 |
Treatments |
|
| MYF3001 | P3 |
Active, not recruiting |
Myelofibrosis |
2028-06-30 |
40% |
2025-10-28 |
Primary Endpoints |
| GRN163LMYF3001 | P3 |
Recruiting |
Myelofibrosis |
2027-12-31 |
40% |
2025-05-02 |
Treatments |
| 63935937MDS3001 | P3 |
Active, not recruiting |
Myelodysplastic Syndrome |
2026-10-13 |
2025-05-02 |
||
| 2020-003288-24 | P3 |
Active, not recruiting |
Myelofibrosis |
2026-06-10 |
40% |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/05/2025 |
News Article |
Geron Corporation Reports Third Quarter 2025 Financial Results and Recent Business Highlights |
|
11/04/2025 |
News Article |
Geron Corporation to Present at Upcoming Investor Conferences |
|
11/03/2025 |
News Article |
Geron Corporation Announces Five Presentations Selected for ASH 2025 Highlighting Clinical Activity of RYTELO® (imetelstat) in Myeloid Hematologic Malignancies |
|
10/20/2025 |
News Article |
Geron Corporation Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) |
|
03/08/2024 |
PubMed |
Imetelstat: Finally a disease-modifying treatment for lower-risk myelodysplastic syndromes? |
|
02/01/2024 |
PubMed |
Phase to phase: Navigating drug combinations with hypomethylating agents in higher-risk MDS trials for optimal outcomes. |
|
01/01/2024 |
PubMed |
Telomerase inhibitor imetelstat kills AML cells via lipid ROS and ferroptosis. |