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Drug

Mogamulizumab

Approved · EMA
Late-stage development

Also known as Poteligeo.

RxNorm2054068UNIIYI437801BE
9
Active clinical trials
1
Regulatory events
Latest activity
beta

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

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Clinical trial2026-07-01Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas

Clinical trial2026-05-05Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Multi-center Randomized Clinical Trial to Determine the Safety and Effectiveness of A-dmDT390-bisFv(UCHT1) Fusion Protein (VG712) in Subjects With Mycosis Fungoides (CurbMF Trial)

Clinical trial2026-04-14Results expected Q4 2030 · ClinicalTrials.gov

Phase II Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

Clinical trial2026-04-14Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1

Clinical trial2026-03-05Results expected Q4 2029 · ClinicalTrials.gov

A Pilot Phase I Trial of IL-21 Expanded, Off the Shelf, Third-Party Natural Killer (NK) Cells in Combination With Mogamulizumab in Patients With Cutaneous T-Cell Lymphomas or Adult T-Cell Leukemia/Lymphomas

Clinical trial2026-02-10Results expected Q4 2026 · ClinicalTrials.gov

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

Clinical trial2025-10-14Results expected Q2 2028 · ClinicalTrials.gov

An Open-Label, Multicenter, Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab (KW-0761) in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

Clinical trial2025-08-12Primary completion · ClinicalTrials.gov

Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

Clinical trial2025-05-01Primary completion · ClinicalTrials.gov

A Phase 1b/2 Study of Hu5F9-G4 (Magrolimab) in Combination With Mogamulizumab in Relapsed/Refractory Treated T-Cell Lymphoma

Clinical trial2024-10-24Terminated · ClinicalTrials.gov

Open-label, Multicenter Phase 1 Study of Mogamulizumab (KW-0761) in Combination With Docetaxel in Previously Treated Subjects With Non-small Cell Lung Cancer (NSCLC)

Clinical trial2024-09-19Results posted · ClinicalTrials.gov

Approval: Poteligeo (EMA)

Regulatory2018-11-22EMA

Profile

Identifiers & mechanism

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

Canonical name
Mogamulizumab
Aliases & brands
Poteligeo
RxNorm CUI
2054068
UNII
YI437801BE
Regulatory jurisdictions
ema

Regulatory timeline

1 event

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
2018-11-22
Latest approval
2018-11-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2018-11-22Approval
Approval: Poteligeo (EMA)

Indication: Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

Evidence ↗

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

Clinical trials

21 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
21
registered trials across all phases
LATEST COMPLETION 2023
9
Active studies
8
Recruiting
1
Late-stage (III+)
7
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 21
Phase 18Phase 1 / 24Phase 28Phase 41

Late-stage studies

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

An Open-Label, Multicenter, Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab (KW-0761) in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

Active, not recruitingPH IVKyowa Kirin China Pharmaceutical Co., Ltd.n=232025

Recent completions

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

A Phase I and Randomized Phase II Study of KW-0761 (Mogamulizumab) and MK-3475 (Pembrolizumab) in Relapsed, Refractory Diffuse Large-B Cell Lymphoma

CompletedPH I/IINational Cancer Institute (NCI)n=82023

Phase 1 Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for Patients With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome

CompletedPH INational Cancer Institute (NCI)n=62022

Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients

CompletedPH IOsaka Universityn=162020

A Phase I/II Study of the Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors

CompletedPH I/IIMemorial Sloan Kettering Cancer Centern=172020

Multicenter, Open-label, Phase 1, Dose-escalation, Cohort-expansion, First-in-Human Study of KHK2455 Administered as Monotherapy and in Combination With Mogamulizumab in Adult Subjects With Locally Advanced or Metastatic Solid Tumors

CompletedPH IKyowa Kirin, Inc.n=362019

Phase 1 Study of Mogamulizumab (KW-0761) in Combination With MEDI4736 (Durvalumab) and Mogamulizumab in Combination With Tremelimumab in Subjects With Advanced Solid Tumors

CompletedPH IKyowa Kirin, Inc.n=642018
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.