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Aracytine (Ara C)
Aracytine (Ara C) is a Nucleoside analog; antimetabolite Small molecule drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 3 development for Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), Chronic myeloid leukemia (CML) in blast phase.
Cytarabine is a nucleoside analog that inhibits DNA synthesis by being incorporated into DNA, leading to chain termination and cell death.
Aracytine (Ara C) is being studied in clinical trials for various types of leukemia, including Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia, Leukemia, Myelocytic, Acute, and Multiple Myeloma. The exact mechanism of Aracytine is not specified in the provided information, but it is being used in combination with other interventions such as Sirolimus, Mitoxantrone, and Etoposide in these clinical trials.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Aracytine (Ara C) |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Drug class | Nucleoside analog; antimetabolite |
| Target | DNA polymerase; incorporated into DNA |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Cytarabine (Ara-C) is a pyrimidine antimetabolite that mimics cytidine and is phosphorylated intracellularly to its active triphosphate form. This active metabolite inhibits DNA polymerase and is incorporated into DNA, causing chain termination and apoptosis. It is primarily effective against rapidly dividing cells, particularly hematopoietic malignancies.
Approved indications
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Chronic myeloid leukemia (CML) in blast phase
- Lymphoma
Common side effects
- Myelosuppression (neutropenia, thrombocytopenia, anemia)
- Nausea and vomiting
- Mucositis
- Hepatotoxicity
- Neurotoxicity (at high doses)
- Infection
Key clinical trials
- Testing the Addition of the Anti-cancer Drug Venetoclax and/or the Anti-cancer Immunotherapy Blinatumomab to the Usual Chemotherapy Treatment for Infants With Newly Diagnosed KMT2A-rearranged or KMT2A-non-rearranged Leukemia (PHASE2)
- A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed B-Lymphoblastic Leukemia (PHASE3)
- Pediatric-Inspired Regimen Combined With Venetoclax and Immunotherapy for Adult Ph-Negative Acute Lymphoblastic Leukemia (NA)
- Testing the Addition of Venetoclax or Gemtuzumab Ozogamicin (GO) to Usual Treatment Regimen (Cytarabine and Daunorubicin, "7+3") for Core Binding Factor Acute Myeloid Leukemia (CBF-AML) to Improve Response (A MyeloMATCH Treatment Trial) (PHASE2)
- Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (PHASE3)
- Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1 (PHASE3)
- Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial) (PHASE2)
- MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) (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:
- Aracytine (Ara C) CI brief — competitive landscape report
- Aracytine (Ara C) updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Aracytine (Ara C)
What is Aracytine (Ara C)?
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Who makes Aracytine (Ara C)?
What drug class is Aracytine (Ara C) in?
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What does Aracytine (Ara C) target?
Related
- Drug class: All Nucleoside analog; antimetabolite drugs
- Target: All drugs targeting DNA polymerase; incorporated into DNA
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia (AML)
- Indication: Drugs for Acute lymphoblastic leukemia (ALL)
- Indication: Drugs for Chronic myeloid leukemia (CML) in blast phase
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing