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BR-TD-1001
BR-TD-1001 is a Neurotrophin receptor modulator Biologic drug developed by Boryung Biopharma Co., Ltd.. It is currently in Phase 3 development for Alzheimer's disease, Mild cognitive impairment.
BR-TD-1001 is a dual-acting compound that modulates both TrkA and p75NTR signaling pathways involved in neuroinflammation and neurodegeneration.
BR-TD-1001 is a vaccine intended to prevent Diphtheria and Tetanus, as indicated by ClinicalTrials.gov. It is administered intramuscularly to healthy children in a double-blind, randomized Phase III study to evaluate its immunogenicity and safety.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | BR-TD-1001 |
|---|---|
| Sponsor | Boryung Biopharma Co., Ltd. |
| Drug class | Neurotrophin receptor modulator |
| Target | TrkA, p75NTR |
| Modality | Biologic |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
The drug targets neurotrophic signaling pathways implicated in neurodegenerative diseases. By modulating TrkA (tropomyosin receptor kinase A) and p75 neurotrophin receptor, BR-TD-1001 aims to reduce neuroinflammation and promote neuroprotection, potentially slowing disease progression in conditions characterized by neuronal loss.
Approved indications
- Alzheimer's disease
- Mild cognitive impairment
Common side effects
Key clinical trials
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:
- BR-TD-1001 CI brief — competitive landscape report
- BR-TD-1001 updates RSS · CI watch RSS
- Boryung Biopharma Co., Ltd. portfolio CI
Frequently asked questions about BR-TD-1001
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Related
- Drug class: All Neurotrophin receptor modulator drugs
- Target: All drugs targeting TrkA, p75NTR
- Manufacturer: Boryung Biopharma Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Alzheimer's disease
- Indication: Drugs for Mild cognitive impairment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing