Last reviewed · How we verify
Ara-C in induction-2
Ara-C in induction-2 is a Small molecule drug developed by PETHEMA Foundation. It is currently in Phase 2 development.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Ara-C in induction-2 |
|---|---|
| Sponsor | PETHEMA Foundation |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
- Pyrexia
- Nausea
- Diarrhoea
- Febrile neutropenia
- Vomiting
- Hypokalaemia
- Rash
- Anaemia
- Constipation
- Headache
- Thrombocytopenia
- Mucosal inflammation
Key clinical trials
- CPX-351 vs Intensive Chemotherapy in Patients With de Novo Intermediate or Adverse Risk AML Stratified by Genomics (PHASE2)
- Liposomal Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin for the Treatment of Relapsed Refractory Pediatric Patients With Acute Myeloid Leukemia (PHASE1)
- Mature B-Cell Lymphoma And Leukemia Study III (PHASE2, PHASE3)
- UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML (EARLY_PHASE1)
- Study of Standard Intensive Chemotherapy Versus Intensive Chemotherapy With CPX-351 in Adult Patients With Newly Diagnosed AML and Intermediate- or Adverse Genetics (PHASE3)
- Chemoradiotherapy With Targeted Immunotherapy in Pediatric Lymphoma (PHASE2)
- A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML) (PHASE3)
- Fludarabine in Combination With Daunorubicin and Cytarabine Liposome in Newly-diagnosed Acute Myeloid Leukemia. (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:
- Ara-C in induction-2 CI brief — competitive landscape report
- Ara-C in induction-2 updates RSS · CI watch RSS
- PETHEMA Foundation portfolio CI
Frequently asked questions about Ara-C in induction-2
What is Ara-C in induction-2?
Who makes Ara-C in induction-2?
What development phase is Ara-C in induction-2 in?
What are the side effects of Ara-C in induction-2?
Related
- Manufacturer: PETHEMA Foundation — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing