Momelotinib

Overview

Momelotinib is a Janus Kinase 1 (JAK1) and 2 (JAK2) inhibitor. It is a competitive inhibitor of JAK ATP binding. First approved by the FDA on September 15, 2023, momelotinib is used to treat myelofibrosis. Myelofibrosis (MF) is a group of myeloproliferative neoplasms characterized by abnormal proliferative hematopoietic stem cells, leading to the release of cytokines and growth factors. MF includes primary MF (PMF), post-polycythemia vera (PV) MF, and post-essential thrombocythemia (ET) MF. Clinical manifestations of MF include anemia and thrombocytosis. Momelotinib works to block the JAK-signal transducer and activator of transcription (STAT) signalling pathway, which is aberrant in MF.

Indication

Momelotinib is indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [postpolycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

Associated Conditions

High risk Myelofibrosis
Intermediate risk Myelofibrosis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Momelotinib During and After HCT in Myelofibrosis	2025/08/05	NCT07104799	Not Applicable	Not yet recruiting	Massachusetts General Hospital
Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia	2025/07/17	NCT07071155	Not Applicable	Not yet recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome	2025/02/26	NCT06847867	Phase 2	Recruiting	GlaxoSmithKline
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis	2024/07/24	NCT06517875	Phase 2	Recruiting	GlaxoSmithKline
A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia	2024/02/01	NCT06235801	Phase 1	Recruiting	M.D. Anderson Cancer Center
A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia	2023/08/08	NCT05980806	Phase 2	Recruiting	Karyopharm Therapeutics Inc
Managed Access Program for Momelotinib in Myelofibrosis	2022/10/17	NCT05582083	N/A	NO_LONGER_AVAILABLE	GlaxoSmithKline
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 of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis	2019/11/25	NCT04176198	Phase 1	Recruiting	Sumitomo Pharma America, Inc.
A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)	2019/11/22	NCT04173494	Phase 3	Completed	Sierra Oncology LLC - a GSK company

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ojjaara	GlaxoSmithKline LLC	81864-101	ORAL	200 mg in 1 1	9/15/2023
Ojjaara	GlaxoSmithKline LLC	81864-102	ORAL	150 mg in 1 1	9/15/2023
Ojjaara	GlaxoSmithKline LLC	81864-103	ORAL	100 mg in 1 1	9/15/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Omjjara	GlaxoSmithKline Trading Services Limited,12 Riverwalk,Citywest Business Campus,Dublin 24,D24 YK11,Ireland	Authorised	1/25/2024

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
OMJJARA FILM-COATED TABLET 100 MG	Patheon Inc.	SIN17131P	TABLET, FILM COATED	100 mg	11/1/2024
OMJJARA FILM-COATED TABLET 200 MG	Patheon Inc.	SIN17133P	TABLET, FILM COATED	200 mg	11/1/2024
OMJJARA FILM-COATED TABLET 150 MG	Patheon Inc.	SIN17132P	TABLET, FILM COATED	150 mg	11/1/2024

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
OMJJARA TABLETS 150MG	N/A	葛兰素史克	N/A	N/A	12/13/2024
OMJJARA TABLETS 200MG	N/A	葛兰素史克	N/A	N/A	12/13/2024
OMJJARA TABLETS 100MG	N/A	葛兰素史克	N/A	N/A	12/13/2024

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
OMJJARA momelotinib (as dihydrochloride monohydrate) 150 mg film-coated tablet bottle	442231	GlaxoSmithKline Australia Pty Ltd	Medicine	A	12/18/2024
OMJJARA momelotinib (as dihydrochloride monohydrate) 200 mg film-coated tablet bottle	442232	GlaxoSmithKline Australia Pty Ltd	Medicine	A	12/18/2024
OMJJARA momelotinib (as dihydrochloride monohydrate) 100 mg film-coated tablet bottle	442230	GlaxoSmithKline Australia Pty Ltd	Medicine	A	12/18/2024

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.

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The 2025 ASCO Annual Meeting highlighted significant progress in myelofibrosis treatment, featuring novel JAK inhibitors like momelotinib and pacritinib that offer alternatives to standard ruxolitinib therapy.

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