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Drug

Pomalidomide

Established medicine
ClassCRL4(CRBN) E3 ubiquitin ligase inhibitorResearchOngoing clinical research

Also known as Pomalyst, Pomalidomida.

RxNorm1369713ChEMBLCHEMBL43452ATCL04AX06UNIID2UX06XLB5
2
Research papers
69
Active clinical trials
4
Protein targets
12
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In

Clinical trial2026-09-03Results expected Q4 2027 · ClinicalTrials.gov

Approval: POMALIDOMIDE (ANDA210232)

Regulatory2026-08-31FDA

Approval: POMALIDOMIDE (ANDA213234)

Regulatory2026-08-31FDA

Approval: POMALIDOMIDE (ANDA219718)

Regulatory2026-08-31FDA

Approval: POMALIDOMIDE (ANDA220741)

Regulatory2026-08-31FDA

The Safety and Efficacy of Pomadomide in Combination With Rituximab and Methotrexate for Newly-diagnosed Primary Central Nervous System Lymphoma : A Prospective, Multicenter, Phase I/II Study

Clinical trial2026-08-31Primary completion · ClinicalTrials.gov

A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Clinical trial2026-08-30Primary completion · ClinicalTrials.gov

A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Subjects With Multiple Myeloma

Clinical trial2026-08-28Results expected Q2 2027 · ClinicalTrials.gov

A Phase 3 Randomized Study Comparing Talquetamab SC in Combination With Daratumumab SC and Pomalidomide (Tal-DP) or Talquetamab SC in Combination With Daratumumab SC (Tal-D) Versus Daratumumab SC, Pomalidomide and Dexamethasone (DPd), in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received at Least 1 Prior Line of Therapy

Clinical trial2026-08-28Results expected Q3 2027 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Clinical trial2026-08-27Status changed to Active, not recruiting · ClinicalTrials.gov

Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection.

Research2022-03-01Clinical cancer research : an official journal of the American Association for Cancer Research

Pomalidomide for Symptomatic Kaposi's Sarcoma in People With and Without HIV Infection: A Phase I/II Study.

Research2016-10-31Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pomalidomide
Aliases & brands
PomalystPomalidomida
RxNorm CUI
1369713
ChEMBL ID
CHEMBL43452
ATC codes
L04AX06
UNII
D2UX06XLB5
Primary mechanism
CRL4(CRBN) E3 ubiquitin ligase inhibitor
Regulatory jurisdictions
emamhrafda

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Protein cereblon
CRBN · Q96SW2
INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor
DNA damage-binding protein 1
DDB1 · Q16531
INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor
Cullin-4A
CUL4A · Q13619
INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor
E3 ubiquitin-protein ligase RBX1
RBX1 · P62877
INHIBITORCRL4(CRBN) E3 ubiquitin ligase inhibitor

Regulatory timeline

12 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-08-05
Latest approval
2026-08-31
Authorities
FDA · EMA · MHRA
Total events
12
fdaU.S. Food and Drug Administration· 4 events
2026-08-31Approval
Approval: POMALIDOMIDE (ANDA219718)
Evidence ↗
2026-08-31Approval
Approval: POMALIDOMIDE (ANDA220741)
Evidence ↗
2026-08-31Approval
Approval: POMALIDOMIDE (ANDA213234)
Evidence ↗
emaEuropean Medicines Agency· 6 events
2024-11-14Approval
Approval: Pomalidomide Teva (EMA)
Indication: Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior… Show full indication

Pomalidomide Teva in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Teva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. 

Evidence ↗
2024-07-26Approval
Approval: Pomalidomide Accord (EMA)
Indication: Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior… Show full indication

Pomalidomide Accord in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Accord in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. 

Evidence ↗
2024-07-24Approval
Approval: Pomalidomide Zentiva (EMA)
Indication: Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Zentiva in combination with dexamethasone is… Show full indication

Treatment of adults with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Pomalidomide Zentiva in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2016-05-10Safety communicationSafety
Drug Safety Update: Pomalidomide (Imnovid▼): risk of hepatitis B reactivation
Evidence ↗
2015-05-20Safety communicationSafety
Drug Safety Update: Pomalidomide (Imnovid▼): risks of cardiac failure, interstitial lung disease and hepatotoxicity
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

193 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
193
registered trials across all phases
LATEST COMPLETION 2026
69
Active studies
34
Recruiting
40
Late-stage (III+)
66
Completed
58
Discontinued
PHASE DISTRIBUTIONn = 193
Early Phase 11Phase 146Phase 1 / 238Phase 268Phase 334Phase 41Phase N / A5

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

An Open-Label, Non-Comparative, Two-Cohort, Multicenter Study to Evaluate the Effectiveness and Safety of Ixazomib (NINLARO®) in Combination With Pomalidomide and Dexamethasone (IPd, Cohort A) or With Lenalidomide and Dexamethasone (IRd, Cohort B) in Patients With Relapsed/Refractory Multiple Myeloma Previously Receiving a Parenteral Proteasome Inhibitor-based Treatment Regimen (US MM-7)

WithdrawnPH IVTakeda2026

An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma

RecruitingPH IIIRegeneron Pharmaceuticalsn=9152034

An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

RecruitingPH IIIRegeneron Pharmaceuticalsn=4102033

A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma

RecruitingPH IIIJuno Therapeutics, Inc., a Bristol-Myers Squibb Companyn=4402032

A Phase 3 Randomized Study Comparing Teclistamab Monotherapy Versus Pomalidomide, Bortezomib, Dexamethasone (PVd) or Carfilzomib, Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma Who Have Received 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Monoclonal Antibody and Lenalidomide

Active, not recruitingPH IIIJanssen Research & Development, LLCn=6142031

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)

CompletedPH IIICelgenen=3862026

An Open-Label, Multicenter Phase 1b Study Investigating the Safety of TAK-079 in Combination With Backbone Regimens for the Treatment of Patients With Newly Diagnosed Multiple Myeloma and for Whom Stem Cell Transplantation Is Not Planned as Initial Therapy

CompletedPH ITakedan=502026

Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab

CompletedPH IIBristol-Myers Squibbn=672026

Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment With Pomalidomide, Dexamethasone, and Carfilzomib (PdC) in Subjects With Relapsed and Relapsed/Refractory Multiple Myeloma

CompletedPH I/IIUniversity of Chicagon=252025

Autologous Stem Cell Transplant With Pomalidomide (CC-4047®) Maintenance Versus Continuous Clarithromycin/ Pomalidomide / Dexamethasone Salvage Therapy in Relapsed or Refractory Multiple Myeloma: A Phase 2 Open-Label Randomized Study by Tristate Consortium

CompletedPH IIMemorial Sloan Kettering Cancer Centern=232025

A Phase 2, Multicenter, Multi-cohort, Open-label Study of Pomalidomide in Combination With Low-dose Dexamethasone or Pomalidomide in Combination With Low-dose Dexamethasone and Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Following Lenalidomide Based Therapy in the First or Second Line Setting.

CompletedPH IICelgenen=1862025

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20162022
Most influential

Pomalidomide for Symptomatic Kaposi's Sarcoma in People With and Without HIV Infection: A Phase I/II Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016 · 96 cites

Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2022 · 38 cites
Recent papers

Safety, Activity, and Long-term Outcomes of Pomalidomide in the Treatment of Kaposi Sarcoma among Individuals with or without HIV Infection.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2022 · 38 cites

Pomalidomide for Symptomatic Kaposi's Sarcoma in People With and Without HIV Infection: A Phase I/II Study.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2016 · 96 cites
Major research themes4
Herpesvirus 8, Human1HIV Infections1Sarcoma, Kaposi1Venous Thromboembolism1
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Polizzotto MN2
  • Steinberg SM2
  • Uldrick TS2
  • Whitby D2
  • Wyvill KM2
  • Yarchoan R2
  • Aleman K1
  • Bevans M1
Leading institutions
free-text, unnormalised
  • Center for Cancer Research1
  • Frederick National Laboratory for Cancer Research1
  • National Cancer Institute; Margaret Bevans1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.