TheraRadar
Data updated: May 26, 2026

MELPHALAN HYDROCHLORIDE

Oncology Approved 2009-06-09
Jump to: Indications Approvals Trials Competitors Safety Patents
18
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Discontinued
First Approved
2009-06-09
Routes
INJECTION, INTRAVENOUS
Dosage Forms
INJECTABLE, POWDER

Companies

Viatris GLAND HETERO LABS PH HEALTH Hikma Teva BPI LABS MEITHEAL Dr. Reddy's USWM ARTHUR GRP ALMAJECT NOVAST LABS AVET LIFESCIENCES SAGENT PHARMS INC Fresenius Kabi
Active Ingredient: MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
21 FDA actions from 2009 to 2024
Oct 2024 ORIGINAL
Update
May 2024 ORIGINAL
Update
May 2023 SUPPL
Label · Labeling

What MELPHALAN HYDROCHLORIDE Treats

18 FDA approvals

Originally approved for its first indication in 2009 . Covers 18 distinct patient populations.

  • Other (18)
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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NCT03328936 OSU-17082 NCI-2017-01702, P30CA016058 Ph 2 withdrawn Study of Personalized Melphalan Dosing in the Setting of Autologous Transplant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
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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

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Data Sources

FDA Approval: ANDA090299 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.