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Zinecard
Zinecard is a Small molecule drug developed by M.D. Anderson Cancer Center. It is currently in Phase 1 development for Doxorubicin Induced Cardiomyopathy, Extravasation Injury from Anthracycline Injection, Prevention of CMV Disease After Organ Transplant. Also known as: Dexrazoxane.
Zinecard, also known as dexrazoxane hydrochloride, is a cardioprotective agent used to prevent cardiotoxicity associated with certain chemotherapy agents. It works as an iron sequestering agent, binding to iron to prevent its interaction with other molecules.
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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). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| 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 | Zinecard |
|---|---|
| Also known as | Dexrazoxane |
| Sponsor | M.D. Anderson Cancer Center |
| Target | DNA topoisomerase 2-beta, DNA topoisomerase 2-alpha |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 1 |
Approved indications
- Doxorubicin Induced Cardiomyopathy
- Extravasation Injury from Anthracycline Injection
- Prevention of CMV Disease After Organ Transplant
Common side effects
Key clinical trials
- Risk-Based Therapy in Treating Younger Patients With Newly Diagnosed Liver Cancer (PHASE3)
- Venetoclax Basket Trial for High Risk Hematologic Malignancies (PHASE1)
- Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
- A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations (PHASE3)
- Testing a Standardized Approach to Surgery and Chemotherapy for Type I Pleuropulmonary Blastoma or the Addition of an Anti-cancer Drug, Topotecan, to the Usual Treatment for Types II and III Pleuropulmonary Blastoma (PHASE3)
- Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (PHASE3)
- Pediatric Classical Hodgkin Lymphoma Consortium Study: cHOD17 (PHASE2)
- 05-001: Treatment of Acute Lymphoblastic Leukemia in Children (PHASE3)
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:
- Zinecard CI brief — competitive landscape report
- Zinecard updates RSS · CI watch RSS
- M.D. Anderson Cancer Center portfolio CI
Frequently asked questions about Zinecard
What is Zinecard?
What is Zinecard used for?
Who makes Zinecard?
Is Zinecard also known as anything else?
What development phase is Zinecard in?
What does Zinecard target?
Related
- Target: All drugs targeting DNA topoisomerase 2-beta, DNA topoisomerase 2-alpha
- Manufacturer: M.D. Anderson Cancer Center — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Doxorubicin Induced Cardiomyopathy
- Indication: Drugs for Extravasation Injury from Anthracycline Injection
- Indication: Drugs for Prevention of CMV Disease After Organ Transplant
- Also known as: Dexrazoxane
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing