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Bionetide
Bionetide is a Small molecule drug developed by Biomed Industries, Inc.. It is currently in Phase 3 development. Also known as: NA-921.
Bionetide is being investigated as a potential treatment for Rett Syndrome in a Phase 3 clinical trial. The trial, NCT06840496, is a randomized, double-blind, placebo-controlled study comparing the efficacy of oral Bionetide to placebo in females with Rett Syndrome.
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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 | Bionetide |
|---|---|
| Also known as | NA-921 |
| Sponsor | Biomed Industries, Inc. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome (PHASE3)
- To Study the Efficacy & Safety of Oral NA-921 (Bionetide) in Girls and Women with Rett Syndrome (PHASE2, 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:
- Bionetide CI brief — competitive landscape report
- Bionetide updates RSS · CI watch RSS
- Biomed Industries, Inc. portfolio CI
Frequently asked questions about Bionetide
What is Bionetide?
Who makes Bionetide?
Is Bionetide also known as anything else?
What development phase is Bionetide in?
Related
- Manufacturer: Biomed Industries, Inc. — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: NA-921
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing