Duvelisib
- Generic Name
- Duvelisib
- Brand Names
- Copiktra
- Drug Type
- Small Molecule
- Chemical Formula
- C22H17ClN6O
- CAS Number
- 1201438-56-3
- Unique Ingredient Identifier
- 610V23S0JI
- Background
Duvelisib, also known as IPI-145 and INK-1197, is a small-molecule inhibitor of phosphoinositide-3 kinases that was designed initially to prove that simultaneous inhibition of the isoforms delta and gamma can produce a broad adaptative and innate immune cell inhibitory activity. All the work around duvelisib showed that this agent is a potent inhibitor of both forms. Duvelisib was developed by Verastem, Inc and FDA approved on September 24, 2018.
- Indication
Duvelisib is indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adult patients who have trialed at least two prior therapies.
- Associated Conditions
- Refractory Small Lymphocytic Lymphoma, Relapsed Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia (CLL), Relapsed Small Lymphocytic Lymphoma
A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
- Conditions
- Small Lymphocytic LymphomaChronic Lymphocytic Leukemia
- Interventions
- First Posted Date
- 2013-12-09
- Last Posted Date
- 2023-09-21
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 319
- Registration Number
- NCT02004522
Phase 1 Study in Healthy Subjects to Evaluate the Effect of Rifampin on the Pharmacokinetics of IPI-145
- Conditions
- Healthy
- First Posted Date
- 2013-09-20
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 14
- Registration Number
- NCT01947777
- Locations
- 🇺🇸
PRA International, Inc, Lenexa, Kansas, United States
Phase 1 Study in Healthy Subjects to Evaluate the Effect of IPI-145 on the Pharmacokinetics of Midazolam
- Conditions
- Healthy
- First Posted Date
- 2013-08-20
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 14
- Registration Number
- NCT01925911
- Locations
- 🇺🇸
PRA International, Lenexa, Kansas, United States
A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma
- First Posted Date
- 2013-06-20
- Last Posted Date
- 2023-09-07
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 129
- Registration Number
- NCT01882803
Study of IPI-145 in Combination With Rituximab or Bendamustine/Rituximab in Hematologic Malignancies
- Conditions
- Chronic Lymphocytic LeukemiaNon-Hodgkin LymphomaT-cell LymphomaLymphoma
- Interventions
- First Posted Date
- 2013-06-07
- Last Posted Date
- 2016-07-11
- Lead Sponsor
- SCRI Development Innovations, LLC
- Target Recruit Count
- 48
- Registration Number
- NCT01871675
- Locations
- 🇺🇸
Florida Cancer Specialists, Sarasota, Florida, United States
🇺🇸Tennessee Oncology, PLLC, Nashville, Tennessee, United States
🇺🇸Oklahoma University, Oklahoma City, Oklahoma, United States
A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone
- First Posted Date
- 2013-05-10
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 322
- Registration Number
- NCT01851707
IPI-145 ADME and Absolute Bioavailability Study
- First Posted Date
- 2013-04-22
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 6
- Registration Number
- NCT01836861
- Locations
- 🇳🇱
Pharmaceuticals Research Association (PRA), Zuidlaren, Netherlands
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
- First Posted Date
- 2012-03-08
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- SecuraBio
- Target Recruit Count
- 106
- Registration Number
- NCT01549106
- Locations
- 🇳🇱
PRA International, Zuidlaren, Netherlands
Drug Development Updates
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