Ojjaara

(Momelotinib)

ApprovedSmall molecule

Momelotinib is used to treat myelofibrosis, a rare blood cancer where the bone marrow becomes scarred and can't produce enough normal blood cells. It works by blocking certain proteins that cause the disease to progress.[2] Ojjaara is currently approved and in use across 10 indications[4].[1]

Ojjaara is one of 157 small molecule programs targeting Primary Myelofibrosis. It is currently in Approved.

Indications

Total Trials

Active Trials

156

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Primary MyelofibrosisApproved

Familial ThrombocytosisApproved

Polycythemia VeraApproved

ThrombocytosisApproved

SplenomegalyActive, not recruiting

Myeloproliferative DisorderActive, not recruiting

MyelofibrosisCompleted

Myelodysplastic SyndromeRecruiting

ThrombocytopeniaRecruiting

Myelodysplastic SyndromesNot yet recruiting

Primary MyelofibrosisApproved

Approved

Familial ThrombocytosisApproved

Approved

Polycythemia VeraApproved

Approved

ThrombocytosisApproved

Approved

SplenomegalyApproved

Active, not recruiting

Myeloproliferative DisorderApproved

Active, not recruiting

MyelofibrosisApproved

Completed

Myelodysplastic SyndromePhase 2

Recruiting

ThrombocytopeniaPhase 2

Recruiting

Myelodysplastic SyndromesPhase 1

Not yet recruiting

Competition

Competitive Landscape

61 competitors in Myelodysplastic Syndrome

#DrugCompanyPhaseTrials

Dacogen

Sun Pharmaceutical Industries, Inc.

Approved

42 2

Neoral

Novartis

Approved

10 3

Exjade

Novartis

Approved

5 4

Cytosar

Teva

Phase 3

41 5

Venclexta

AbbVie

Phase 3

17 6

Vidaza

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

60 7

Fludara

Sanofi

Phase 3

16 8

Danocrine

Rocaltrol

Idamycin

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Myelofibrosis

NCT06517875

Q2 2028

Phase 1Recruiting

Neoplasms

NCT06150157

Q3 2028

Phase 1Not yet recruiting

Myelodysplastic Syndromes

NCT07071155

Q4 2028

Phase 2Recruiting

Thrombocytopenia

NCT05980806

PreclinicalNot yet recruiting

Myelofibrosis

NCT07734077

Clinical

Trials by Indication[1]

Myelofibrosis8 trials

Managed Access Program for Momelotinib in Myelofibrosis

No longer available· GSK logo

GSK··NCT05582083

Momelotinib During and After HCT in Myelofibrosis

Recruiting·MMassachusetts General Hospital·Phase 1·NCT07104799·28 enrolled

A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM)

Completed·—·Phase 3·NCT04173494·195 enrolled

Show 5 more trials

Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis

Recruiting· GSK logo

GSK·Phase 2·NCT06517875·56 enrolled

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Completed·—·Phase 3·NCT01969838·432 enrolled

A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis

Not yet recruiting·SSWOG Cancer Research Network·Approved·NCT07498205·268 enrolled

A Phase 1/2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis

Recruiting· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Preclinical·NCT04176198·240 enrolled

Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis

Not yet recruiting·JJohn Mascarenhas·Preclinical·NCT07734077·32 enrolled

Essential Thrombocythemia5 trials

Safety and Efficacy of Momelotinib in Subjects With Polycythemia Vera or Essential Thrombocythemia

Terminated·—·Phase 2·NCT01998828·39 enrolled

Extension Study Evaluating the Long Term Safety and Efficacy Study of CYT387 in Primary Myelofibrosis (PMF) or Post-polycythemia Vera (PV) or Post-essential Thrombocythemia (ET)

Completed·—·Phase 2·NCT01236638·120 enrolled

Safety Study Evaluating Twice-Daily Administration of Momelotinib in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis

Completed·—·Phase 1/2·NCT01423058·61 enrolled

Show 2 more trials

Efficacy of Momelotinib Versus Best Available Therapy in Anemic or Thrombocytopenic Subjects With Primary Myelofibrosis (MF), Post-polycythemia Vera MF, or Post-essential Thrombocythemia MF

Completed·—·Phase 3·NCT02101268·156 enrolled

Long-term Safety and Efficacy of Momelotinib in Subjects With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis, Polycythemia Vera or Essential Thrombocythemia

Completed·—·Phase 2·NCT02124746·87 enrolled

Pancreatic Ductal Adenocarcinoma2 trials

Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma

Terminated·—·Phase 1·NCT02244489·16 enrolled

Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Terminated·—·Phase 3·NCT02101021·25 enrolled

Non-Small Cell Lung Cancer2 trials

Efficacy and Safety of Momelotinib Combined With Trametinib in Adults With Metastatic KRAS-mutated Non-Small Cell Lung Cancer (NSCLC) Who Have Failed Platinum-Based Chemotherapy Preceded by a Dose-finding Lead-in Phase

Terminated·—·Phase 1·NCT02258607·21 enrolled

Erlotinib and Momelotinib for the Treatment of Epidermal Growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naive Metastatic Non-Small Cell Lung Cancer (NSCLC)

Terminated·—·Phase 1·NCT02206763·11 enrolled

Myelodysplastic Syndrome1 trial

A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome

Recruiting· GSK logo

GSK·Phase 2·NCT06847867·80 enrolled

4 more indications

Thrombocytopenia1 trial

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Recruiting·KKaryopharm Therapeutics Inc·Phase 2·NCT05980806·58 enrolled

Myelodysplastic Syndromes1 trial

Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia

Not yet recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT07071155·18 enrolled

Neoplasms1 trial

A First-in-Human Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ 88549968, a T-cell Redirecting Bispecific Antibody for CALR-mutated Myeloproliferative Neoplasms

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT06150157·300 enrolled

Myeloid Leukemia1 trial

A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06235801·40 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 15, 2023

OJJAARA

NDA NDA216873

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Momelotinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ojjaara drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Momelotinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Momelotinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216873). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ojjaara. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Glaxo Dba Glaxosmithkline company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Activin Receptor Type-1 Inhibitor; Tyrosine-Protein Kinase JAK1 Inhibitor; Tyrosine-Protein Kinase JAK2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: GGlaxo Dba Glaxosmithkline

Patent Landscape[6]

Patent Cliff

Jan 3, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8486941Jan 3, 2030

9809559Jun 11, 2035

RE48285Jun 11, 2035

12576089Aug 21, 2039

11963962Dec 2, 2040

Ojjaara

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2028

Q3 2028

Q4 2028

Trials by Indication[1]

Myelofibrosis8 trials

Essential Thrombocythemia5 trials

Pancreatic Ductal Adenocarcinoma2 trials

Non-Small Cell Lung Cancer2 trials

Myelodysplastic Syndrome1 trial

Thrombocytopenia1 trial

Myelodysplastic Syndromes1 trial

Neoplasms1 trial

Myeloid Leukemia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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