Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/03 | Phase 1 | Not yet recruiting | |||
2025/02/06 | Phase 1 | Not yet recruiting | |||
2024/07/26 | Phase 3 | Recruiting | SecuraBio | ||
2023/06/28 | N/A | Not yet recruiting | |||
2022/08/19 | Phase 1 | Not yet recruiting | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | ||
2021/10/04 | Phase 1 | Completed | |||
2021/09/27 | Phase 2 | Active, not recruiting | Glenn J. Hanna | ||
2021/09/14 | Phase 1 | Active, not recruiting | |||
2021/08/18 | Phase 1 | Recruiting | |||
2021/05/18 | Early Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Verastem, Inc. | 71779-115 | ORAL | 15 mg in 1 1 | 2/11/2022 | |
| Secura Bio, Inc. | 73116-215 | ORAL | 15 mg in 1 1 | 10/1/2021 | |
| Secura Bio, Inc. | 73116-225 | ORAL | 25 mg in 1 1 | 10/1/2021 | |
| Verastem, Inc. | 71779-125 | ORAL | 25 mg in 1 1 | 2/11/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/19/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Duvelisib Capsules | 国药准字HJ20220017 | 化学药品 | 胶囊剂 | 3/16/2022 | |
| Duvelisib Capsules | 国药准字HJ20220018 | 化学药品 | 胶囊剂 | 3/16/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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