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Aramchol
Aramchol is a Small molecule drug developed by Galmed Pharmaceuticals Ltd. It is currently in Phase 2 development. Also known as: arachidyl amido cholanoic acid, 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate, Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid).
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Aramchol |
|---|---|
| Also known as | arachidyl amido cholanoic acid, 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate, Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid), 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid |
| Sponsor | Galmed Pharmaceuticals Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Single and Multiple Dose Pharmacokinetics (PK) of Aramchol From an Aramchol Meglumine Tablet (PHASE1)
- A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR) (PHASE3)
- Comparing The PK Of Aramchol Meglumine Granules To Aramchol Free Acid Tablets (PHASE1)
- A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis (PHASE2)
- Open-Label Study to Evaluate the Safety, Tolerability, and PK of Aramchol in Subjects With Hepatic Impairment (PHASE1)
- An Open-Label, Two-Part Study Designed to Assess the Absolute Bioavailability and Mass Balance of Aramchol (PHASE1)
- A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH (PHASE2)
- Aramchol for HIV-associated Nonalcoholic Fatty Liver Disease and Lipodystrophy (PHASE2)
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:
- Aramchol CI brief — competitive landscape report
- Aramchol updates RSS · CI watch RSS
- Galmed Pharmaceuticals Ltd portfolio CI
Frequently asked questions about Aramchol
What is Aramchol?
Who makes Aramchol?
Is Aramchol also known as anything else?
What development phase is Aramchol in?
Related
- Manufacturer: Galmed Pharmaceuticals Ltd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: arachidyl amido cholanoic acid, 3β-arachidylamido-7α,12α,dihydroxy 5β-cholan-24-oic acid), fatty-acid bile-acid conjugate, Aramchol free acid (3β-arachidylamido-7α,12α-dihydroxy-5β-cholan-24-oic acid), 3β-arachidylamino-7α,12α-dihydroxy-5β-cholan-24-oic acid
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing