Overview
An alkylating agent of value against both hematologic malignancies and solid tumors.
Background
An alkylating agent of value against both hematologic malignancies and solid tumors.
Indication
For the treatment of primary and metastatic brain tumors as a component of combination chemotherapy in addition to appropriate surgical and/or radiotherapeutic procedures. Also used in combination with other agents as secondary therapy for the treatment of refractory or relapsed Hodgkin's disease.
Associated Conditions
- Metastatic Brain Tumors
- Primary Brain Neoplasm
- Refractory Hodgkin Lymphoma
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/05/17 | Phase 3 | Not yet recruiting | Vastra Gotaland Region | ||
2024/03/28 | Phase 2 | Recruiting | Philogen S.p.A. | ||
2024/03/22 | Phase 2 | Suspended | |||
2024/02/28 | N/A | Recruiting | Jasper Gerritsen | ||
2023/12/20 | Phase 2 | Recruiting | Darell Bigner | ||
2023/06/15 | Phase 3 | Recruiting | |||
2023/06/13 | Phase 3 | Recruiting | |||
2022/06/08 | Not Applicable | Withdrawn | Varun Monga, MD | ||
2022/05/19 | Phase 3 | Recruiting | |||
2022/03/31 | Phase 1 | Withdrawn | Philogen S.p.A. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| NextSource Biotechnology, LLC | 58181-3042 | ORAL | 100 mg in 1 1 | 1/23/2024 | |
| NextSource Biotechnology, LLC | 58181-3040 | ORAL | 10 mg in 1 1 | 1/23/2024 | |
| NextSource Biotechnology, LLC | 58181-3041 | ORAL | 40 mg in 1 1 | 1/23/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| Lomustine Capsules | 国药准字H37020834 | 化学药品 | 胶囊剂 | 4/4/2020 | |
| Lomustine Capsules | 国药准字H22026586 | 化学药品 | 胶囊剂 | 7/24/2020 | |
| Lomustine Capsules | 国药准字H32021377 | 化学药品 | 胶囊剂 | 7/22/2020 | |
| Lomustine Capsules | 国药准字H22020950 | 化学药品 | 胶囊剂 | 7/24/2020 | |
| Lomustine Capsules | 国药准字H37020835 | 化学药品 | 胶囊剂 | 4/4/2020 | |
| Lomustine Capsules | 国药准字H23022390 | 化学药品 | 胶囊剂 | 6/29/2020 |
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 |
|---|---|---|---|---|---|
| CEENU 40mg capsule bottle | 19249 | Link Medical Products Pty Ltd T/A Link Pharmaceuticals | Medicine | A | 9/30/1991 |
| CEENU 10mg capsule bottle | 19252 | Medicine | A | 9/30/1991 |