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Donamet (ADEMETIONINE)
Donamet (generic name: ADEMETIONINE) is a ademetionine drug. It is currently in Phase 3 development.
Donamet works by inhibiting the enzyme Phenylethanolamine N-methyltransferase, which plays a role in the breakdown of certain neurotransmitters.
Donamet is a small molecule with the synonyms adenosylmethionine (ADEMETIONINA, ADEMETIONINE, etc.).
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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 | ADEMETIONINE |
|---|---|
| Drug class | ademetionine |
| Target | Protein-beta-aspartate methyltransferase, Phenylethanolamine N-methyltransferase, Protein arginine N-methyltransferase 1 |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 3 |
Mechanism of action
Think of it like a traffic cop: Donamet helps regulate the flow of certain chemicals in the brain by blocking the enzyme that breaks them down. This can help maintain a healthy balance of these chemicals, which is essential for various bodily functions.
Approved indications
Common side effects
- Confabulation
- Serotonin syndrome
- Nystagmus
- Right aortic arch
- Congenital arterial malformation
- Rhabdomyolysis
- Drug interaction
- Dyskinesia
- Mechanical urticaria
- Foetal exposure during pregnancy
- Myelosuppression
- Clonus
Key clinical trials
- Single-Center Phase II Double-Blind Trial of SAMe to Prevent Liver Cancer in MASLD-Related Cirrhosis (PHASE2)
- Ademetionine in Obstructive Hypertrophic Cardiomyopathy (PHASE2)
- SAMe in Prevention of Oxaliplatin-associated Liver Injury (PHASE2)
- Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia (NA)
- Development of a Diagnostic Prediction Score for Tuberculosis in Hospitalized Children With Severe Acute Malnutrition (TB-Speed SAM) (NA)
- SAMe Trial for Patients With Alcoholic Cirrhosis (PHASE2)
- From Yearly Checks to Daily Progress: Evaluating Goal Attainment Scaling (GAS) in Systematic Work Environment Management (SAM) Within the Municipal Sector (NA)
- Trial of Rice-Based F-75 in Severe Malnutrition & Persistent Diarrhea in Children (SAM-RICE Study) (NA)
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:
- Donamet CI brief — competitive landscape report
- Donamet updates RSS · CI watch RSS
Frequently asked questions about Donamet
What is Donamet?
How does Donamet work?
What is the generic name of Donamet?
What drug class is Donamet in?
What development phase is Donamet in?
What are the side effects of Donamet?
What does Donamet target?
Related
- Drug class: All ademetionine drugs
- Target: All drugs targeting Protein-beta-aspartate methyltransferase, Phenylethanolamine N-methyltransferase, Protein arginine N-methyltransferase 1
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing