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Ademetionine tablet
Ademetionine tablet is a Amino acid derivative / Methyl donor Small molecule drug developed by Abbott. It is currently in Phase 3 development for Cholestasis and intrahepatic cholestasis of pregnancy, Hepatic cirrhosis and liver dysfunction, Depression (secondary indication in some markets).
Ademetionine is a methyl donor that replenishes cellular S-adenosylmethionine (SAM) levels to support methylation reactions and hepatic function.
Ademetionine is a small molecule used in the treatment of various conditions, including depressive symptoms, major depressive disorder, and obstructive hypertrophic cardiomyopathy, among others. It is available in tablet form and has been studied in clinical trials, including a randomized, double-blind, placebo-controlled study to evaluate its efficacy in subjects with mild to moderate depression symptoms.
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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 | Ademetionine tablet |
|---|---|
| Sponsor | Abbott |
| Drug class | Amino acid derivative / Methyl donor |
| Target | S-adenosylmethionine (SAM) pathway |
| Modality | Small molecule |
| Therapeutic area | Hepatology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Ademetionine (also known as SAMe) is the active form of methionine that serves as the primary methyl donor in the body. It participates in critical methylation reactions involved in neurotransmitter synthesis, phospholipid metabolism, and antioxidant defense. By restoring depleted SAM levels, it supports hepatocyte regeneration and improves liver function in cholestasis and hepatic disorders.
Approved indications
- Cholestasis and intrahepatic cholestasis of pregnancy
- Hepatic cirrhosis and liver dysfunction
- Depression (secondary indication in some markets)
Common side effects
- Gastrointestinal disturbance
- Nausea
- Headache
- Insomnia
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)
- SAMe Trial for Patients With Alcoholic Cirrhosis (PHASE2)
- S-adenosylmethionine (SAMe) in Patients With Primary Sclerosing Cholangitis (PSC) (NA)
- Examination of Zinc, S-adenosylmethionine, and Combination Therapy Versus Placebo in Alcoholics (NA)
- Sumor as Adjuvant Therapy in Treatment-resistant Major Depression (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:
- Ademetionine tablet CI brief — competitive landscape report
- Ademetionine tablet updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about Ademetionine tablet
What is Ademetionine tablet?
How does Ademetionine tablet work?
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What does Ademetionine tablet target?
Related
- Drug class: All Amino acid derivative / Methyl donor drugs
- Target: All drugs targeting S-adenosylmethionine (SAM) pathway
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Hepatology / Gastroenterology
- Indication: Drugs for Cholestasis and intrahepatic cholestasis of pregnancy
- Indication: Drugs for Hepatic cirrhosis and liver dysfunction
- Indication: Drugs for Depression (secondary indication in some markets)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing