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 15 indications[4].[1]

Ojjaara is one of 319 small molecule programs targeting Polycythemia Vera. It is currently in Approved.

Indications

Total Trials

Active Trials

318

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Polycythemia VeraApproved

ThrombocytopeniaActive, not recruiting

Primary MyelofibrosisApproved

Familial ThrombocytosisApproved

SplenomegalyActive, not recruiting

Pancreatic Ductal AdenocarcinomaActive, not recruiting

MyelofibrosisActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

Non-Small Cell Lung CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Polycythemia VeraApproved

Approved

ThrombocytopeniaPhase 2

Active, not recruiting

Primary MyelofibrosisApproved

Approved

Familial ThrombocytosisApproved

Approved

SplenomegalyApproved

Active, not recruiting

Pancreatic Ductal AdenocarcinomaPhase 3

Active, not recruiting

MyelofibrosisPhase 3

Active, not recruiting

Myelodysplastic SyndromePhase 2

Active, not recruiting

Non-Small Cell Lung CancerPhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 1/Phase 2

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

1639 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Ojjaara

GGlaxo Dba Glaxosmithkline

Approved

2 2

Yervoy

Bristol-Myers Squibb

Preclinical

31 3

Gemzar

GGynecologic Oncology Group

Preclinical

72 4

PORTRAZZA

Eli Lilly

Preclinical

8 5

Lenvima

Eisai

Preclinical

6 6

Vizimpro

Pfizer

Preclinical

4 7

Ofev

Boehringer Ingelheim

Preclinical

7 8

Immunotherapy

Bristol-Myers Squibb

Preclinical

12 9

Remeron

OOrganon and Co

Preclinical

1 10

PD-1 Inhibitor

Johnson & Johnson

Preclinical

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

Clinical

Trials by Indication[1]

Myelofibrosis6 trials

Managed Access Program for Momelotinib in Myelofibrosis

No longer available· GSK logo

GSK··NCT05582083

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

Completed·—·Phase 3·NCT04173494·195 enrolled

Momelotinib Versus Ruxolitinib in Subjects With Myelofibrosis

Completed·—·Phase 3·NCT01969838·432 enrolled

Show 3 more trials

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

Recruiting· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 1/2·NCT04176198·240 enrolled

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

Recruiting· GSK logo

GSK·Phase 2·NCT06517875·56 enrolled

Momelotinib During and After HCT in Myelofibrosis

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

Essential Thrombocythemia5 trials

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

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

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

Terminated·—·Phase 2·NCT01998828·39 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

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

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

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

Acute 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·Phase 1/2·NCT06235801·20 enrolled

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

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·NCT06150157·241 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 15, 2023

OJJAARA

NDA NDA216873

Sources

References

[1]
ClinicalTrials.gov — 20 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]

Myelofibrosis6 trials

Essential Thrombocythemia5 trials

Pancreatic Ductal Adenocarcinoma2 trials

Non-Small Cell Lung Cancer2 trials

Myelodysplastic Syndrome1 trial

Myelodysplastic Syndromes1 trial

Acute Myeloid Leukemia1 trial

Thrombocytopenia1 trial

Neoplasms1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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