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Melphalan, Carboplatin
Melphalan, Carboplatin is a Small molecule drug developed by Wills Eye. It is currently in Phase 1 development. Also known as: ALKERAN,PARAPLATIN.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Melphalan, Carboplatin |
|---|---|
| Also known as | ALKERAN,PARAPLATIN |
| Sponsor | Wills Eye |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
- 58300-Neutrophil count decreased
- 65800-Platelet count decreased
- Infection
- Pneumonia
- Diarrhea
- ALT increased
- 43100-Hypokalemia
- Febrile neutropenia
- Fluid overload
- Oral mucositis
- Nausea
- Rash
Key clinical trials
- Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
- Intra-Arterial Chemotherapy for Newly Diagnosed, Residual, or Recurrent Atypical Choroid Plexus Papilloma and Choroid Plexus Carcinoma Prior to Second-Look Surgery (PHASE1)
- Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
- A Study to Give Treatment Inside the Eye to Treat Retinoblastoma (PHASE2)
- Ocular Conservative Treatment for Retinoblastoma : Efficacy of the New Management Strategies and Visual Outcome (PHASE2, PHASE3)
- Conservative Treatments of Retinoblastoma (PHASE2)
- Myeloablative Consolidation Therapy and Tandem Autologous Stem Cell Rescue in Patients With High-Risk Neuroblastoma (PHASE2)
- Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Melphalan, Carboplatin CI brief — competitive landscape report
- Melphalan, Carboplatin updates RSS · CI watch RSS
- Wills Eye portfolio CI
Frequently asked questions about Melphalan, Carboplatin
What is Melphalan, Carboplatin?
Who makes Melphalan, Carboplatin?
Is Melphalan, Carboplatin also known as anything else?
What development phase is Melphalan, Carboplatin in?
What are the side effects of Melphalan, Carboplatin?
Related
- Manufacturer: Wills Eye — full pipeline
- Also known as: ALKERAN,PARAPLATIN
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing