Pomalidomide clinical trials
Pomalidomide is named as an intervention in 71 current clinical trials in our USA, China, France, Spain, UK, Australia, Germany, Japan, Italy, Canada, South Korea, Poland, Israel, Brazil, Belgium, Czechia, Netherlands, Sweden, Turkey, Taiwan, Denmark, Norway, Austria, Portugal, Mexico, Singapore, India, Ireland, Switzerland and Egypt registers. 39 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Janssen Research & Development, LLC (10). The most-studied condition is Multiple Myeloma. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Pomalidomide is approved
All regulators →Of the three regulators tracked here, the first to approve Pomalidomide was the US, on 8 Feb 2013. It is approved in 3 of the 3 regulators tracked here.
- 5 EU orphan designations, most recently for treatment of systemic sclerosis (26 Apr 2012, withdrawn)
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.
Pomalidomide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Pomalidomide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 21 Dec 2031 (US 8828427, including a 6-month paediatric extension).
- Latest patent on the drug substance itself: 21 Dec 2031 (US 8828427, with paediatric extension).
- Exclusivity PED: Pediatric exclusivity, until 14 Nov 2027.
- Exclusivity ODE-296: Orphan drug exclusivity: indicated for the treatment of adult patients with aids-related kaposi sarcoma (ks) after failure of highly active…, until 14 May 2027.
- Exclusivity ODE-297: Orphan drug exclusivity: for the treatment of kaposi sarcoma (ks) in adult patients who are HIV-negative, until 14 May 2027.
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 Pomalidomide
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 Pomalidomide works
All drug targets →- CRL4(CRBN) E3 ubiquitin ligase inhibitor InhibitorTarget: CRL4(CRBN) E3 ubiquitin ligase✓ In ChEMBL and the Guide to Pharmacology
- AnemiaPhase 3
- MyelofibrosisPhase 3
- AL amyloidosisPhase 2
- B-cell chronic lymphocytic leukemiaPhase 2
- HIV infectious diseasePhase 2
- Kaposi's sarcomaPhase 2
- Richter transformationPhase 2
- Acute monocytic leukemiaPhase 2
- Acute myeloid leukemiaPhase 2
- AmyloidosisPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL43452, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7348, 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 Pomalidomide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Pomalidomide. 3 are current, and 1 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Pomalidomide with bortezomib and dexamethasone for treating relapsed or refractory multiple myeloma (terminated appraisal) NICE TA602 | Terminated (no company submission) | 25 Sep 2019 | Current |
| Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib NICE TA427 | Recommended | 11 Jan 2017 | Current |
| Pomalidomide for relapsed and refractory multiple myeloma previously treated with lenalidomide and bortezomib NICE TA338 | Not recommended | 25 Mar 2015 | 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 Pomalidomide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 36 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Imnovid (previously Pomalidomide Celgene), Pomalidomide Accord (generic), Pomalidomide Krka (generic), Pomalidomide Teva (generic), Pomalidomide Viatris (generic), Pomalidomide Zentiva (generic)EMA 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.
Reference identifiers for Pomalidomide
- ATC code
- L04AX06
- ChEMBL
- CHEMBL43452
- DrugBank
- DB17419
- PubChem CID
- 134780
- CAS number
- 19171-19-8
- FDA UNII
- D2UX06XLB5
- Wikidata
- Q7227206
- Wikipedia
- Pomalidomide
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Pomalidomide
71 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.
Pomalidomide in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pomalidomide. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Pomalidomide 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)
36 single-substance products containing Pomalidomide on the HPRA medicines list.
- Pomalidomide Clonmel 1 mg hard capsulesClonmel Healthcare Ltd · PA0126/378/001 · Marketed
- Pomalidomide Clonmel 2 mg hard capsulesClonmel Healthcare Ltd · PA0126/378/002 · Marketed
- Pomalidomide Clonmel 3 mg hard capsulesClonmel Healthcare Ltd · PA0126/378/003 · Marketed
- Pomalidomide Clonmel 4 mg hard capsulesClonmel Healthcare Ltd · PA0126/378/004 · Marketed
- Pomalidomide Rowex 2 mg hard capsulesRowex Limited, · PA0711/338/002 · Marketed
Supply shortages
No entry for Pomalidomide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Pomalidomide
40 conditionsAll 40 conditions
| Condition (as registered) | Trials |
|---|---|
| Multiple Myeloma | 39 |
| Relapsed or Refractory Multiple Myeloma | 6 |
| Multiple Myeloma in Relapse | 4 |
| Relapsed/Refractory Multiple Myeloma | 3 |
| Relapsed or Refractory Multiple Myeloma (RRMM) | 2 |
| Multiple Myeloma Refractory | 2 |
| Relapsed Refractory Multiple Myeloma (RRMM) | 2 |
| Plasma Cell Myeloma Recurrent | 1 |
| Relapsed Refractory Multiple Myeloma | 1 |
| Relapsed and/or Refractory Multiple Myeloma (RRMM) | 1 |
| Haematological Malignancy | 1 |
| Acute Myeloid Leukemia | 1 |
| Non Hodgkin Lymphoma | 1 |
| Plasma Cell Myeloma | 1 |
| Smoldering Multiple Myeloma | 1 |
| Immunoglobulin Light-chain Amyloidosis | 1 |
| Plasma Cell Myeloma Refractory | 1 |
| Myeloma | 1 |
| Myeloma Multiple | 1 |
| Systemic Amyloidosis | 1 |
| Mantle Cell Lymphoma (MCL) | 1 |
| POZ | 1 |
| Indolent Lymphoma | 1 |
| Follicular Lymphoma | 1 |
| Marginal Zone Lymphoma | 1 |
| Indolent Mantle Cell Lymphoma | 1 |
| PCNSL | 1 |
| Light Chain (AL) Amyloidosis | 1 |
| Primary Central Nervous System Lymphoma (PCNSL) | 1 |
| Diffuse Large B Cell Lymphoma (DLBCL) | 1 |
| Multiple Myeloma (MM) | 1 |
| Hematological Malignancy | 1 |
| Solid Tumor | 1 |
| Deletion 17P Syndrome | 1 |
| HIV-1 Infection | 1 |
| Refractory Multiple Myeloma | 1 |
| Relapse | 1 |
| Relapse Multiple Myeloma | 1 |
| Relapsed and/or Refractory Multiple Myeloma | 1 |
| Systemic Lupus Erythematosus (SLE) | 1 |
Sponsors
lead sponsor per trial+ 24 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Pomalidomide trials
How many clinical trials are testing Pomalidomide?
71 current trials in our USA, China, France, Spain, UK, Australia, Germany, Japan, Italy, Canada, South Korea, Poland, Israel, Brazil, Belgium, Czechia, Netherlands, Sweden, Turkey, Taiwan, Denmark, Norway, Austria, Portugal, Mexico, Singapore, India, Ireland, Switzerland and Egypt registers name Pomalidomide (also registered as CCS1477) as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Pomalidomide trials recruiting patients?
Yes. 39 of the 71 trials are recruiting: 23 with sites in USA, 22 with sites in China, 17 with sites in France, 15 with sites in Spain, 16 with sites in UK, 16 with sites in Australia, 13 with sites in Germany, 13 with sites in Japan, 11 with sites in Italy, 12 with sites in Canada, 13 with sites in South Korea, 9 with sites in Poland, 13 with sites in Israel, 11 with sites in Brazil, 6 with sites in Belgium, 6 with sites in Czechia, 6 with sites in Netherlands, 5 with sites in Sweden, 5 with sites in Turkey, 7 with sites in Taiwan, 4 with sites in Denmark, 6 with sites in Norway, 3 with sites in Austria, 4 with sites in Portugal, 1 with sites in Mexico, 3 with sites in Singapore, 1 with sites in India, 1 with sites in Ireland, 1 with sites in Switzerland and 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pomalidomide clinical trials?
Janssen Research & Development, LLC (10), GlaxoSmithKline (6), AbbVie (6) and Sanofi (3), among 39 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Pomalidomide clinical trials in Ireland?
Yes. 2 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 Pomalidomide licensed in Ireland?
Yes. The HPRA medicines list includes 36 single-substance products containing Pomalidomide, for example Pomalidomide Clonmel 1 mg hard capsules (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Pomalidomide shortage?
Not in the lists we track: Pomalidomide 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 Pomalidomide 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 Pomalidomide 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 Pomalidomide (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 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.