Last reviewed · How we verify
Amitriptyline Oxide (AMITRIPTYLINOXIDE)
Amitriptyline Oxide (generic name: AMITRIPTYLINOXIDE) is a drug. It is currently in Phase 3 development.
Amitriptylinoxide works by binding to and inhibiting the proto-oncogene tyrosine-protein kinase receptor Ret.
Amitriptylinoxide is a small molecule modality targeting the proto-oncogene tyrosine-protein kinase receptor Ret. However, due to the lack of available information, its exact mechanism of action, approved indications, and commercial status are unknown. Further research is needed to determine its potential as a therapeutic agent. As a result, it is not possible to provide a comprehensive summary of its key safety considerations. More data is required to understand its pharmacokinetic properties and potential side effects.
-
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 | AMITRIPTYLINOXIDE |
|---|---|
| Target | Proto-oncogene tyrosine-protein kinase receptor Ret |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Think of it like a key fitting into a lock. Amitriptylinoxide is the key that blocks the receptor, which is like a switch that controls cell growth. By blocking this switch, amitriptylinoxide may help slow down or stop the growth of cancer cells.
Approved indications
Common side effects
Key clinical trials
- Pharmacovigilance in Gerontopsychiatric Patients (PHASE3)
- Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene (PHASE4)
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:
- Amitriptyline Oxide CI brief — competitive landscape report
- Amitriptyline Oxide updates RSS · CI watch RSS
Frequently asked questions about Amitriptyline Oxide
What is Amitriptyline Oxide?
How does Amitriptyline Oxide work?
What is the generic name of Amitriptyline Oxide?
What development phase is Amitriptyline Oxide in?
What does Amitriptyline Oxide target?
Related
- Target: All drugs targeting Proto-oncogene tyrosine-protein kinase receptor Ret
- Therapeutic area: All drugs in Oncology
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing