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ALRN-6924 in combination with cytarabine
ALRN-6924 in combination with cytarabine is a MDM2/MDMX inhibitor combination therapy Small molecule drug developed by Aileron Therapeutics, Inc.. It is currently in Phase 1 development. Also known as: ALRN-6924 in combination with Ara-C.
ALRN-6924 is a stapled peptide that inhibits MDM2 and MDMX proteins to restore p53 tumor suppressor activity, combined with cytarabine DNA synthesis inhibition.
ALRN-6924 is a protein modality being studied in combination with cytarabine for various conditions, including Acute Myeloid Leukemia, Myelodysplastic Syndromes, Leukemia, Brain Tumor, and Solid Tumor. The combination of ALRN-6924 and cytarabine is being investigated in a Phase 1/1b clinical trial (NCT02909972) to determine its safety and tolerability.
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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 | ALRN-6924 in combination with cytarabine |
|---|---|
| Also known as | ALRN-6924 in combination with Ara-C |
| Sponsor | Aileron Therapeutics, Inc. |
| Drug class | MDM2/MDMX inhibitor combination therapy |
| Modality | Small molecule |
| Phase | Phase 1 |
Mechanism of action
ALRN-6924 is a cell-permeating stapled peptide that binds to and inhibits both MDM2 and MDMX, negative regulators of the p53 tumor suppressor protein. By blocking these interactions, it restores p53 function to induce cancer cell death. Cytarabine is a nucleoside analog that inhibits DNA synthesis, providing complementary anti-cancer activity.
Approved indications
Common side effects
Key clinical trials
- Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer (PHASE1)
- Safety Study of ALRN-6924 in Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome (PHASE1)
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:
- ALRN-6924 in combination with cytarabine CI brief — competitive landscape report
- ALRN-6924 in combination with cytarabine updates RSS · CI watch RSS
- Aileron Therapeutics, Inc. portfolio CI
Frequently asked questions about ALRN-6924 in combination with cytarabine
What is ALRN-6924 in combination with cytarabine?
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Is ALRN-6924 in combination with cytarabine also known as anything else?
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Related
- Drug class: All MDM2/MDMX inhibitor combination therapy drugs
- Manufacturer: Aileron Therapeutics, Inc. — full pipeline
- Also known as: ALRN-6924 in combination with Ara-C
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing