# Momelotinib

Momelotinib (Omjjara, GlaxoSmithKline Trading Services Limited) has 1 EU-approved indication in 1 tumour type.

## Approved indications

### Myeloproliferative neoplasms

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| None | Monotherapy | Any line | Myelofibrosis only; Janus Kinase (JAK) inhibitor naïve or have been treated with ruxolitinib; Moderate to severe anaemia; disease-related splenomegaly or symptoms |

## Products

### Omjjara

- Company: GlaxoSmithKline Trading Services Limited
- Target: JAK1/JAK2 and ACVR1 inhibitor
- EU approval: 25 Jan 2024
- Label revised: 8 Jun 2026
- Status: orphan medicine
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/omjjara-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/omjjara-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara

Mechanism (SmPC section 5.1): Inhibits JAK1, JAK2 (including mutant JAK2 V617F) and STAT signalling, and directly inhibits ACVR1, lowering hepcidin and increasing iron availability and red blood cell production.

## Label wording

- **Momelotinib** (Omjjara), Myeloproliferative neoplasms, any line: “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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/omjjara-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/momelotinib