IVRA (melphalan hydrochloride)
IVRA (melphalan hydrochloride) is an alkylating drug indicated for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. It serves as an intravenous alternative for disease management when oral administration is contraindicated or clinically unsuitable.
How IVRA Works
Melphalan is a bifunctional alkylating agent of the bischloroethylamine type. It exerts its cytotoxic effect by forming interstrand cross-links with DNA, primarily by binding at the N7 position of guanine. This process inhibits DNA synthesis and function, making the drug active against both resting and rapidly dividing tumor cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-08-18
- Patent Cliff
- 2036
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
IVRA Approval History
What IVRA Treats
1 indicationsIVRA is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
IVRA Boxed Warning
SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulat...
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions [see Warnings and Precautions ( 5.4 )] . Melphalan produces chromosomal aberrations in vitro and in vivo . IVRA should be considered potentially leukemogenic in humans [see Warnings and Precautions ( 5.5 )]. WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY See full prescribing information for complete boxed warning. Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor hematologic laboratory parameters ( 5.1 ). Hypersensitivity reactions, including anaphylaxis, have occurred in approximately 2% of patients who received the intravenous formulation of melphalan. Discontinue treatment with IVRA for serious hypersensitivity reactions ( 5.4 ). Melphalan produces chromosomal aberrations in vitro and in vivo. IVRA should be considered potentially leukemogenic in humans ( 5.5 ).
IVRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IVRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IVRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IVRA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 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 |
| NCT01805934 | rjyyxhk2013-01 | Ph 2 | completed | Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection |
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.
IVRA FDA Label Details
Indications & Usage
FDA Label (PDF)IVRA is indicated for the treatment of Multiple Myeloma.
WARNING: SEVERE BONE MARROW SUPPRESSION, HYPERSENSITIVITY and LEUKEMOGENICITY Severe bone marrow suppression with resulting infection or bleeding may occur. Controlled trials comparing intravenous melphalan to oral melphalan have shown more myelosuppression with the intravenous formulation. Monitor ...
IVRA Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for IVRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 1 active patents
Trial Analysis
- • 10 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment