Product Description
Duvelisib is used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that has come back or after 2 or more types of treatment that did not work well. (Sourced from: https://www.mayoclinic.org/drugs-supplements/duvelisib-oral-route/side-effects/drg-20444077?p=1)
Mechanisms of Action: PI3K Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Lymphoma|T-Cell Lymphoma|T-Cell Peripheral Lymphoma *
Approval Status: Approved
Approved Countries: Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Italy | Latvia | Lithuania | Netherlands | Poland | Portugal | Russia | Saudi Arabia | Slovakia | United Arab Emirates | United States
Approved Indications: Chronic Leukemia | Chronic Lymphoid Leukemia | Leukemia | Lymphoid Leukemia | Lymphoma
Known Adverse Events: Pain Unspecified | Colitis | Anemia | Neutropenia | Musculoskeletal Pain | Pneumonia | Diarrhea
Company: SecuraBio
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, Czech Republic, Germany, Italy, Japan, Korea, Poland, Russia, United Kingdom, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: T-Cell Peripheral Lymphoma
Phase 2: COVID-19|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer|Head and Neck Cancer|Lymphoma, Non-Hodgkin|Melanoma|Oncology Hematological Unspecified
Phase 1: Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| TERZO | P3 |
Not yet recruiting |
T-Cell Peripheral Lymphoma |
2028-02-01 |
|
| NCT04331119 | P2 |
Active, not recruiting |
T-Cell Peripheral Lymphoma |
2026-07-31 |
|
| 5R35CA210084 | P1 |
Recruiting |
Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Lymphoma, Non-Hodgkin |
2025-12-31 |
|
| HE1801-CSP-001 | P2 |
Not yet recruiting |
Gastrointestinal Cancer|Head and Neck Cancer|Colorectal Cancer|Esophageal Cancer |
2024-09-20 |
49% |
| HE1801-CSP-001 | P2 |
Not yet recruiting |
Gastrointestinal Cancer|Head and Neck Cancer|Colorectal Cancer|Esophageal Cancer |
2024-09-20 |
49% |