Imetelstat

Overview

Imetelstat is under investigation in clinical trial NCT01916187 (Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy	2024/02/08	NCT06247787	Phase 1	Recruiting	Children's Oncology Group
Expanded Access for Treatment With Imetelstat	2023/07/10	NCT05937568	N/A	APPROVED_FOR_MARKETING	Geron Corporation
Study to Evaluate Imetelstat in Patients With High-Risk MDS or AML Failing HMA-based Therapy	2022/10/17	NCT05583552	Phase 2	Active, not recruiting	GCP-Service International West GmbH
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis	2022/05/12	NCT05371964	Phase 1	Recruiting	Geron Corporation
A Study Comparing Imetelstat Versus Best Available Therapy for the Treatment of Intermediate-2 or High-risk Myelofibrosis (MF) Who Have Not Responded to Janus Kinase (JAK)-Inhibitor Treatment	2020/10/06	NCT04576156	Phase 3	Recruiting	Geron Corporation
Study to Evaluate Imetelstat (GRN163L) in Participants With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)	2015/11/06	NCT02598661	Phase 2	Active, not recruiting	Geron Corporation
Study to Evaluate Activity of 2 Dose Levels of Imetelstat in Participants With Intermediate-2 or High-Risk Myelofibrosis (MF) Previously Treated With Janus Kinase (JAK) Inhibitor	2015/04/24	NCT02426086	Phase 2	Completed	Geron Corporation
Imetelstat Sodium in Treating Younger Patients With Relapsed or Refractory Solid Tumors	2013/12/13	NCT02011126	Phase 2	Withdrawn	Children's Oncology Group
Imetelstat Given Intravenously Alone and With Standard 13-Cis-Retinoic Acid in Children With Neuroblastoma	2013/08/05	NCT01916187	Phase 1	Withdrawn	NCIC Clinical Trials Group
Imetelstat Sodium in Treating Younger Patients With Recurrent or Refractory Brain Tumors	2013/04/22	NCT01836549	Phase 2	Terminated	Pediatric Brain Tumor Consortium

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Rytelo	Geron Netherlands B.V.,La Guardiaweg 58,1043 DJ Amsterdam,Netherlands	Authorised	3/7/2025

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Phase 3 Trial Advances Imetelstat as Potential Game-Changer for JAK Inhibitor-Resistant Myelofibrosis

2 months ago

Imetelstat, a first-in-class telomerase inhibitor, is advancing to phase 3 trials after demonstrating promising survival benefits in patients with myelofibrosis resistant to JAK inhibitor therapy.

Vivo Capital Secures $740 Million for Third Cycle of Healthcare Investment Fund

2 months ago

• Vivo Capital has closed the third cycle of its Opportunity Fund with over $740 million in commitments, focusing on preclinical and clinical-stage life sciences companies developing novel therapies. • The fund has previously backed companies that achieved significant milestones, including FDA approvals for treatments targeting COPD, myelodysplastic syndrome, narcolepsy, and Prader-Willi Syndrome. • Several Vivo-backed companies have been acquired by pharmaceutical giants in billion-dollar deals, including RayzeBio (Bristol-Myers Squibb, $4.1B), Chinook Therapeutics (Novartis, $3.2B), and Sierra Oncology (GSK, $1.9B).

Imetelstat Shows Promise in MDS and Myelofibrosis Treatment, New ASH Data Reveals

5 months ago

New analyses from IMerge Phase 3 trial demonstrate imetelstat's efficacy in lower-risk MDS patients, showing consistent clinical activity regardless of prior treatment history.

Geron Reports Strong Q4 2024 Results with $47.5 Million in RYTELO Revenue, Expects Profitability Without Additional Financing

5 months ago

Geron Corporation achieved $47.5 million in RYTELO (imetelstat) net product revenue in Q4 2024 and $76.5 million since its commercial launch in June 2024, following FDA approval for lower-risk myelodysplastic syndromes.

Imetelstat Plus Ruxolitinib Shows Tolerable Safety in Myelofibrosis Patients

7 months ago

Phase 1/1b IMproveMF trial indicates that the combination of imetelstat and ruxolitinib demonstrates a tolerable safety profile in patients with myelofibrosis.

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