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Atengenal
Atengenal is a Small molecule drug developed by Burzynski Research Institute. It is currently in Phase 3 development. Also known as: A10.
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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).
| 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 | Atengenal |
|---|---|
| Also known as | A10 |
| Sponsor | Burzynski Research Institute |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Effect of Antineoplaston Therapy on the QT/QTc Interval In Subjects With Diffuse, Intrinsic, Brainstem Glioma (PHASE3)
- Study of Antineoplaston Therapy + Radiation vs. Radiation Only in Diffuse, Intrinsic, Brainstem Glioma (PHASE3)
- A Study of Atengenal and Astugenal in Diffuse, Intrinsic Pontine Glioma (DIPG) (PHASE2)
- Antineoplaston Therapy in Treating Children With Low-Grade Astrocytoma (PHASE2)
- Antineoplaston Therapy in Treating Children With Brain Tumors (PHASE2)
- Antineoplaston Therapy in Treating Patients With Ependymoma (PHASE2)
- Antineoplaston Therapy in Treating Patients With Multiple Myeloma (PHASE2)
- Antineoplaston Therapy in Treating Patients With Cancer of the Esophagus (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:
- Atengenal CI brief — competitive landscape report
- Atengenal updates RSS · CI watch RSS
- Burzynski Research Institute portfolio CI
Frequently asked questions about Atengenal
What is Atengenal?
Who makes Atengenal?
Is Atengenal also known as anything else?
What development phase is Atengenal in?
Related
- Manufacturer: Burzynski Research Institute — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: A10
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing