Tafasitamab clinical trials
Tafasitamab is named as an intervention in 14 current clinical trials in our Italy, France, Spain, Austria, South Korea, Israel, UK, USA, China, Germany, Poland, Czechia, Turkey, Canada, Ireland, Belgium, Denmark, Japan, Switzerland, Norway, Taiwan, Australia, Netherlands, Sweden and Brazil registers. 4 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Incyte Corporation (5). The most-studied condition is Follicular Lymphoma.
Where Tafasitamab is approved
All regulators →Of the three regulators tracked here, the first to approve Tafasitamab was the US, on 31 Jul 2020. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of follicular lymphoma (26 Feb 2025, positive)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Tafasitamab patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Tafasitamab, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- Minjuvi for treatment of diffuse large B-cell lymphoma: until 1 Sep 2031. Union Register
- Minjuvi for treatment of follicular lymphoma: until 16 Dec 2035. Union Register
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Tafasitamab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Tafasitamab works
All drug targets →- B-lymphocyte antigen CD19 binding agent Binding agentTarget: CD19 CD19 molecule✓ In ChEMBL and the Guide to Pharmacology
- Follicular lymphomaPhase 3
- Marginal zone lymphomaPhase 3
- B-cell acute lymphoblastic leukemiaPhase 2
- B-cell chronic lymphocytic leukemiaPhase 2
- Richter transformationPhase 2
- Acute lymphoblastic leukemiaPhase 2
- CancerPhase 2
- High grade B-cell lymphomaPhase 2
- LeukemiaPhase 2
- Lymphoid leukemiaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4298047, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 11131, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Tafasitamab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Tafasitamab. 1 is current.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Tafasitamab with lenalidomide for treating relapsed or refractory diffuse large B-cell lymphoma NICE TA883 | Not recommended | 3 May 2023 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Tafasitamab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: MinjuviEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Tafasitamab
14 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Tafasitamab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
1 single-substance product containing Tafasitamab on the HPRA medicines list.
- MINJUVI 200 mg powder for concentrate for solution for infusionIncyte Biosciences Distribution B.V. · EU/1/21/1570/001
Supply shortages
No entry for Tafasitamab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Tafasitamab
15 conditionsAll 15 conditions
| Condition (as registered) | Trials |
|---|---|
| Follicular Lymphoma | 2 |
| Marginal Zone Lymphoma | 2 |
| Diffuse Large B-cell Lymphoma | 2 |
| DLBCL | 2 |
| Large B-Cell Lymphoma | 1 |
| Diffuse Large B-Cell Lymphoma | 1 |
| Lymphoma, Non-Hodgkin | 1 |
| Diffuse Large B Cell Lymphoma | 1 |
| ALL, Childhood B-Cell | 1 |
| Acute Lymphoid Leukemia Relapse | 1 |
| Acute Lymphocytic Leukemia Refractory | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Hematologic Malignancies | 1 |
| Lymphoma, B-Cell | 1 |
| Non Hodgkins Lymphoma | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Tafasitamab trials
How many clinical trials are testing Tafasitamab?
14 current trials in our Italy, France, Spain, Austria, South Korea, Israel, UK, USA, China, Germany, Poland, Czechia, Turkey, Canada, Ireland, Belgium, Denmark, Japan, Switzerland, Norway, Taiwan, Australia, Netherlands, Sweden and Brazil registers name Tafasitamab (also registered as INCMOR00208) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Tafasitamab trials recruiting patients?
Yes. 4 of the 14 trials are recruiting: 1 with sites in Italy, 1 with sites in Spain, 1 with sites in South Korea, 1 with sites in China, 2 with sites in Germany and 1 with sites in Turkey. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Tafasitamab clinical trials?
Incyte Corporation (5), Celgene (1), Beijing InnoCare Pharma Tech Co., Ltd (1) and Institute of Hematology & Blood Diseases Hospital, China (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Tafasitamab clinical trials in Ireland?
Yes. 3 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Tafasitamab licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Tafasitamab, for example MINJUVI 200 mg powder for concentrate for solution for infusion (Incyte Biosciences Distribution B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Tafasitamab shortage?
Not in the lists we track: Tafasitamab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tafasitamab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tafasitamab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tafasitamab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.