MELPHALAN HYDROCHLORIDE · Viatris
MELPHALAN HYDROCHLORIDE is FDA-approved to treat 1 condition (same as HEPZATO).
Details
- Status
- Discontinued
- First Approved
- 2009-06-09
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER
Companies
MELPHALAN HYDROCHLORIDE Approval History
What MELPHALAN HYDROCHLORIDE Treats
1 indicationsMELPHALAN HYDROCHLORIDE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as HEPZATO (same active ingredient).
Viatris's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03192397 results posted | I 44417 NCI-2017-01069, I 44417 | Ph 1, Ph 2 | active not recruiting | Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant |
| NCT03126916 | ANBL1531 NCI-2016-01734, ANBL1531 | Ph 3 | recruiting | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT03417284 results posted | 2017-0399 NCI-2018-00906, 2017-0399 | Ph 1, Ph 2 | completed | Melphalan Hydrochloride in Treating Participants With Newly-Diagnosed Multiple Myeloma Undergoing Donor Stem Cell Transplantation |
| NCT03128359 results posted | 16419 NCI-2017-00480, 16419 | Ph 2 | completed | High Dose Cyclophosphamide, Tacrolimus, and Mycophenolate Mofetil in Preventing Graft Versus Host Disease in Patients With Hematological Malignancies Undergoing Myeloablative or Reduced Intensity Donor Stem Cell Transplant |
| NCT02756572 results posted | 9567 NCI-2016-00477, 9567 | Ph 2 | completed | Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms |
| NCT03328936 | OSU-17082 NCI-2017-01702, P30CA016058 | Ph 2 | withdrawn | Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant |
| NCT01688401 | J11164 NA_00069122 | Ph 1 | completed | Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG). |
| NCT01293539 results posted | J1071 NA_00040637 | Ph 2 | terminated | Intra-arterial Chemotherapy for the Treatment of Intraocular Retinoblastoma |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MELPHALAN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)MELPHALAN HYDROCHLORIDE is FDA-approved to treat 1 condition — same approved indications as HEPZATO.
Looking for the branded version?
HEPZATO
Full clinical data, patents, trials, and competitive landscape for melphalan hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.