POTELIGEO (mogamulizumab-kpkc)
POTELIGEO is indicated for the treatment of Mycosis Fungoides; Sezary Syndrome.
How POTELIGEO Works
Mogamulizumab-kpkc is a humanized monoclonal antibody that binds to CC chemokine receptor type 4 (CCR4), a protein involved in the trafficking of lymphocytes to various organs. This receptor is expressed on the surface of certain T-cell malignancies, as well as regulatory T-cells and specific Th2 T-cells. By binding to CCR4, the drug targets these cells for antibody-dependent cellular cytotoxicity, which results in the depletion of the malignant target cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-08-08
- Patent Cliff
- 2025
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
POTELIGEO Approval History
What POTELIGEO Treats
2 indicationsPOTELIGEO is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mycosis Fungoides
- Sezary Syndrome
POTELIGEO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to POTELIGEO
3 of 19FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05956041 | UMCC 2022.116 HUM00231051, HCRN | Ph 2 | recruiting | Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas |
| NCT07529405 CurbMF | CurbMF-001 | Ph 2 | not yet recruiting | A Study of VG712 in Patients With Mycosis Fungoides |
| NCT05996185 | 2000037447 000 | Ph 2 | recruiting | Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma |
| NCT05414500 | IRB-300006649 (UAB2109) 000535246, 000533654 | Ph 1 | recruiting | Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides |
| NCT06698003 | 21-486 | Ph 2 | recruiting | A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1 |
| NCT04848064 | OSU-20103 NCI-2021-01375 | Ph 1 | recruiting | Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma |
| NCT04541017 results posted | NCI-2020-06710 NCI-2020-06710, PHII-203 | Ph 1, Ph 2 | terminated | Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment |
| NCT04930653 | 20724 NCI-2021-03533, 20724 | Ph 2 | recruiting | Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma |
| NCT06285370 | 0761-CN001 CTR20230672 | Ph 4 | active not recruiting | A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy |
| NCT04256018 | IRB-53490 LYMNHL0155, NCI-2020-05893 | Ph 2 | recruiting | Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome |
| NCT02358473 results posted | 0761-011 | Ph 1 | completed | Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung Cancer |
| NCT04676087 | STUDY00001265 NCI-2020-06013, WINSHIP5101-20 | Ph 1, Ph 2 | terminated | Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides |
| NCT02867007 | 2455-001 | Ph 1 | completed | KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors |
| NCT02301130 | 0761-012 | Ph 1 | completed | Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors |
| NCT04128072 MOGAT | EORTC-1820-CLTF | Ph 2 | recruiting | Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma |
| NCT03309878 results posted | NCI-2017-01865 NCI-2017-01865, 19-018 | Ph 1, Ph 2 | completed | Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma |
| NCT04185220 results posted | 200011 20-C-0011 | Ph 1 | completed | Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome |
| NCT02946671 | KW0761-IIT-02 | Ph 1 | completed | Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
POTELIGEO FDA Label Details
Indications & Usage
FDA Label (PDF)POTELIGEO is indicated for the treatment of Mycosis Fungoides; Sezary Syndrome.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment