> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/momelotinib-d384d174-93c9-4c16-bc43-4bc528bdef0d > Record changed: 2026-10-13 # Momelotinib Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) First approval year 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) ## Development status **First approval year** 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **Drug name** Momelotinib Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **Molecular weight** 414.47 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **Structure (SMILES)** N#CCNC(=O)c1ccc(-c2ccnc(Nc3ccc(N4CCOCC4)cc3)n2)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) ### Other names (22) - cyt 0387 - cyt 11387 - cyt 387 - CYT-0387 - CYT-11387 - Cyt-387 - CYT-387 - cyt387 - CYT387 - gs 0387 - GS-0387 - momelotinib - Momelotinib - Momelotinib (MMB) - momelotinib \[INN\] - Momelotinib \[MI\] - MOMELOTINIB \[USAN\] - Momelotinib \[WHO-DD\] - momelotinib inn - momelotinib mi - momelotinib usan - momelotinib who dd ## Identifiers **ATC classification codes** - L01EJ04 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **CAS registry numbers** - 1056634-68-4 **ChEMBL ID** CHEMBL1078178 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **InChIKey** ZVHNDZWQTBEVRY-UHFFFAOYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1078178) **PubChem compound IDs** - 25062766 **RxNorm IDs (RxCUI)** - 2665204 **FDA ingredient codes (UNII)** - 6O01GMS00P ## Regulatory information ### United States **Applicant** GLAXOSMITHKLINE **Approval date** 15 Sept 2023 **Application number** NDA216873 ### European Union **Status** Authorised **Status date** 25 Jan 2024 **Authorisation date** 25 Jan 2024 **Approved indications** Omjjara is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with moderate to severe anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis and who are Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib. **Product number** EMEA/H/C/005768 **Authorisation holder** GlaxoSmithKline Trading Services Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Myeloproliferative Disorders - Splenomegaly European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** Yes **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** momelotinib **Type** Synthetic organic **Drug name stem** \-tinib **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (7) - **Action** Inhibition **Action type** Inhibitor **Target** Janus kinase 2 **Gene symbol** JAK2 **Protein identifier** O60674 **Median affinity** 8.85 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** Janus kinase 1 **Gene symbol** JAK1 **Protein identifier** P23458 **Median affinity** 7.57 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** tyrosine kinase 2 **Gene symbol** TYK2 **Protein identifier** P29597 **Median affinity** 7.7 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** Janus kinase 3 **Gene symbol** JAK3 **Protein identifier** P52333 **Median affinity** 6.81 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** activin A receptor type 1 **Gene symbol** ACVR1 **Protein identifier** Q04771 **Median affinity** 8.08 **Affinity units** pIC50 - **Mechanism** Tyrosine-protein kinase JAK1 inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase JAK1 **Protein identifier** P23458 - **Mechanism** Tyrosine-protein kinase JAK2 inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase JAK2 **Protein identifier** O60674 ### Open Targets mechanisms (3) - **Mechanism** Activin receptor type-1 inhibitor **Action type** Inhibitor **Target** Activin receptor type-1 - **Mechanism** Tyrosine-protein kinase JAK1 inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase JAK1 - **Mechanism** Tyrosine-protein kinase JAK2 inhibitor **Action type** Inhibitor **Target** Tyrosine-protein kinase JAK2 ### Investigated indications (8) - **Condition** Thrombocythemia, Essential **Highest recorded phase** 2 **Condition identifier** EFO:0000479 **Subject identifier** D013920 - **Condition** Neoplasms **Highest recorded phase** 3 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Polycythemia Vera **Highest recorded phase** 2 **Condition identifier** EFO:0002429 **Subject identifier** D011087 - **Condition** Primary Myelofibrosis **Highest recorded phase** 3 **Condition identifier** EFO:0002430 **Subject identifier** D055728 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 1 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Leukemia, Myeloid **Highest recorded phase** 1 **Condition identifier** MONDO:0004643 **Subject identifier** D007951 - **Condition** Carcinoma, Pancreatic Ductal **Highest recorded phase** 3 **Condition identifier** MONDO:0005184 **Subject identifier** D021441 - **Condition** Primary Myelofibrosis **Highest recorded phase** 3 **Condition identifier** MONDO:0044903 **Subject identifier** D055728 ### Open Targets indications (22) - **Condition identifier** EFO\_0000198 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0002429 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002430 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004251 - **Condition identifier** HP\_0001744 - **Condition identifier** HP\_0001894 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005029 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005184 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0006311 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0009692 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0009891 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0018874 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0018881 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019111 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0019451 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0020311 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0026777 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0044903 - **Condition identifier** MONDO\_0044903 **Highest recorded phase** 4 ### Reported adverse events (2) - **Event** respiratory tract infection **Reports** 3 **Reporting signal score** 13.1696 - **Event** splenomegaly **Reports** 3 **Reporting signal score** 15.2803 ### Trial references (11) - NCT01236638 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01236638) - NCT01423058 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01423058) - NCT01969838 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01969838) - NCT02101268 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02101268) - NCT02124746 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02124746) - NCT01998828 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01998828) - NCT02101021 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02101021) - NCT02244489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02244489) - NCT02206763 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02206763) - NCT02258607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02258607) - NCT06235801 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06235801) ## Dosing **Dose** 200 mg **Route** Oral **How often** Once daily ### Conditions of use - With or without food ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 2 **Polar surface area** 103.17 **Calculated partition coefficient (ALogP)** 2.98 **Calculated partition coefficient (XLogP)** 2.6 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 6 **Heavy atoms** 31 **Molecular formula** C23H22N6O2 **Monoisotopic mass** 414.18042397 **Natural product** Yes ## Evidence counts **Recorded assays** 2,488 **Active assays** 391 ### Active assay types (3) - Confirmatory - Other - Screening ## Pharmacologic actions - Janus Kinase Inhibitors Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000075242.html) - Antineoplastic Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html) ## Biological measurements ### Observed measurements #### Solubility **Median** 0.2 **Mean** 65.65 **Minimum** 0.2 **Maximum** 262 **Unit** ug/mL **Assays** 4 **Standard deviation** 130.9 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility #### Oral bioavailability **Median** 24 **Mean** 24 **Minimum** 24 **Maximum** 24 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F #### Plasma protein binding **Median** 91 **Mean** 91 **Minimum** 91 **Maximum** 91 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - PPB ## Related records ### Trials (26) - A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia - A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) Syndrome - [A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms](https://trialight.com/data/trial/a-study-of-jnj-88549968-for-the-treatment-of-calreticulin-ba23876c-8a4f-4f22-9a4b-adfedd20019f.md) - A Study of Momelotinib in Participants With Low-risk Myelodysplastic Syndrome - A Study of Momelotinib Versus Danazol in Symptomatic and Anemic Myelofibrosis Participants (MOMENTUM) - A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis - A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia - Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts - 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 - 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 - 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) - Extended Access of Momelotinib in Adults With Myelofibrosis - 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) - Gemcitabine and Nab-paclitaxel Combined With Momelotinib in Participants With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma - 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 - Managed Access Program for Momelotinib in Myelofibrosis - Momelotinib Combined With Capecitabine and Oxaliplatin in Adults With Relapsed/Refractory Metastatic Pancreatic Ductal Adenocarcinoma - Momelotinib During and After HCT in Myelofibrosis - Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia - Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF) ### In development for (10) - [Acquired polycythemia vera](https://trialight.com/data/condition/acquired-polycythemia-vera-5c3132a8-49a0-5b93-b3d6-cd5f1fa9e10e.md) Phase 2 - [Essential thrombocythemia](https://trialight.com/data/condition/essential-thrombocythemia-155250c9-5856-5b62-9d8b-794d484c4616.md) Phase 2 - Familial thrombocytosis Phase 2 - [Myelodysplastic syndrome](https://trialight.com/data/condition/myelodysplastic-syndrome-f5df8ce5-6064-53d3-902c-f09fc4acd4bb.md) Phase 2 - Myelofibrosis Phase 3 - [Myeloid leukemia](https://trialight.com/data/condition/myeloid-leukemia-6cc43f22-3c0b-566a-b15d-32a90ad528e5.md) Phase 1 - Neoplasm Phase 3 - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 1 - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) Phase 3 - [Primary myelofibrosis](https://trialight.com/data/condition/primary-myelofibrosis-7777dc52-f40c-5e07-9d67-bcf779b7ff0e.md) Phase 3 ### Targets (3) - [ACVR1](https://trialight.com/data/target/acvr1-d528a65d-e230-51af-8c67-61f171354eca.md) Activin receptor type-1 inhibitor - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) Tyrosine-protein kinase JAK1 inhibitor - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) Tyrosine-protein kinase JAK2 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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