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13-C-Methacetin
13-C-Methacetin is a Diagnostic tracer / Stable isotope breath test Small molecule drug developed by Humedics GmbH. It is currently in Phase 3 development for Assessment of hepatic metabolic function and liver synthetic capacity, Evaluation of cirrhosis severity and prognosis, Monitoring of liver disease progression.
13-C-Methacetin is a stable isotope-labeled tracer used to assess hepatic metabolic function and liver synthetic capacity.
13-C-Methacetin is a stable isotope-labeled tracer used to assess hepatic metabolic function and liver synthetic capacity. Used for Assessment of hepatic metabolic function and liver synthetic capacity, Evaluation of cirrhosis severity and prognosis, Monitoring of liver disease progression.
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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 | 13-C-Methacetin |
|---|---|
| Sponsor | Humedics GmbH |
| Drug class | Diagnostic tracer / Stable isotope breath test |
| Modality | Small molecule |
| Therapeutic area | Diagnostics / Hepatology |
| Phase | Phase 3 |
Mechanism of action
This is a diagnostic agent, not a therapeutic drug. It is a carbon-13 labeled version of methacetin (acetaminophen metabolite) used in breath tests to evaluate liver function by measuring the rate of hepatic metabolism and CO2 production. The 13-C label allows non-invasive assessment of cytochrome P450 activity and overall hepatic reserve.
Approved indications
- Assessment of hepatic metabolic function and liver synthetic capacity
- Evaluation of cirrhosis severity and prognosis
- Monitoring of liver disease progression
Common side effects
Key clinical trials
- BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (PHASE3)
- Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
- MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy (PHASE1)
- Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
- Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
- Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test (PHASE3)
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:
- 13-C-Methacetin CI brief — competitive landscape report
- 13-C-Methacetin updates RSS · CI watch RSS
- Humedics GmbH portfolio CI
Frequently asked questions about 13-C-Methacetin
What is 13-C-Methacetin?
How does 13-C-Methacetin work?
What is 13-C-Methacetin used for?
Who makes 13-C-Methacetin?
What drug class is 13-C-Methacetin in?
What development phase is 13-C-Methacetin in?
Related
- Drug class: All Diagnostic tracer / Stable isotope breath test drugs
- Manufacturer: Humedics GmbH — full pipeline
- Therapeutic area: All drugs in Diagnostics / Hepatology
- Indication: Drugs for Assessment of hepatic metabolic function and liver synthetic capacity
- Indication: Drugs for Evaluation of cirrhosis severity and prognosis
- Indication: Drugs for Monitoring of liver disease progression
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing