Overview
A vesicant and necrotizing irritant destructive to mucous membranes, mechlorethamine is an alkylating drug. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage. The FDA granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel on August 23, 2013 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Each tube of Valchlor contains 0.016% of mechlorethamine which is equivalent to 0.02% mechlorethamine HCl.
Background
A vesicant and necrotizing irritant destructive to mucous membranes, mechlorethamine is an alkylating drug. It was formerly used as a war gas. The hydrochloride is used as an antineoplastic in Hodgkin's disease and lymphomas. It causes severe gastrointestinal and bone marrow damage. The FDA granted marketing approval for the orphan drug Valchlor (mechlorethamine) gel on August 23, 2013 for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy. Each tube of Valchlor contains 0.016% of mechlorethamine which is equivalent to 0.02% mechlorethamine HCl.
Indication
For the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma. Also for the palliative treatment of metastatic carcinoma resulting in effusion.
Associated Conditions
- Bronchogenic Carcinoma
- Chronic Lymphocytic Leukemia
- Hodgkins Disease (HD)
- Lymphoma, Diffuse
- Mycosis Fungoides (MF)
- Polycythemia Vera (PV)
- Stage I Mycosis Fungoides
- Malignant effusion
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/11/28 | Phase 2 | Completed | |||
2022/03/31 | Not Applicable | Completed | Centre for Human Drug Research, Netherlands | ||
2021/11/03 | Not Applicable | Withdrawn | |||
2020/01/06 | Phase 2 | Terminated | |||
2018/01/31 | Phase 2 | Completed | |||
2017/12/20 | Phase 2 | Completed | Rochester Skin Lymphoma Medical Group, PLLC | ||
2017/09/20 | Phase 2 | Withdrawn | |||
2016/11/18 | Early Phase 1 | Completed | |||
2016/08/29 | Phase 2 | UNKNOWN | |||
2014/11/20 | N/A | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Helsinn Therapeutics (U.S.), Inc. | 69639-120 | TOPICAL | 0.012 g in 60 g | 1/12/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/3/2017 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| LEDAGA Topical Gel 160 μg /g | SIN16986P | GEL | 160 μg /g | 4/15/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Chlormethine Hydrochloride Liniment | 国药准字H31022213 | 化学药品 | 搽剂 | 9/6/2023 | |
| Chlormethine Hydrochloride Tincture | 国药准字H41025256 | 化学药品 | 酊剂 | 2/5/2024 | |
| Chlormethine Hydrochloride Injection | 国药准字H20067402 | 化学药品 | 注射剂 | 4/20/2020 | |
| Chlormethine Hydrochloride Injection | 国药准字H31020897 | 化学药品 | 注射剂 | 12/1/2020 |
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 |
|---|---|---|---|---|---|
| LEDAGA chlormethine (as hydrochloride) 160 microgram/g topical gel tube | 338551 | Medicine | A | 6/22/2021 |