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Charcotrace Inj.
Charcotrace Inj. is a Small molecule drug developed by Hanlim Pharm. Co., Ltd.. It is currently in Phase 3 development for Diagnostic imaging of neurological lesions and neural pathways. Also known as: Charcotrace Injection(Activated Charcoal 40mg/1ml).
Charcotrace is a diagnostic imaging agent used to visualize and trace neural pathways and lesions in the central and peripheral nervous system.
Charcotrace Inj. is a medication used to treat breast diseases, as indicated by a clinical trial on ClinicalTrials.gov. The exact mechanism of action of Charcotrace Inj. is not specified in the provided facts, but it is being studied in a clinical trial alongside LuminoMark inj.
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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 | Charcotrace Inj. |
|---|---|
| Also known as | Charcotrace Injection(Activated Charcoal 40mg/1ml) |
| Sponsor | Hanlim Pharm. Co., Ltd. |
| Modality | Small molecule |
| Therapeutic area | Neurology / Diagnostic Imaging |
| Phase | Phase 3 |
Mechanism of action
Charcotrace appears to be a specialized diagnostic tracer or contrast agent designed for neuroimaging applications, likely used in conjunction with imaging modalities to identify neural damage, demyelination, or other neuropathological changes. The name suggests a connection to Charcot disease or related neurological conditions, indicating its use in diagnostic assessment rather than therapeutic intervention.
Approved indications
- Diagnostic imaging of neurological lesions and neural pathways
Common side effects
Key clinical trials
- To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions(Phase 3) (PHASE3)
- To Evaluate the Efficacy and Safety of LuminoMark Injection in Patients With Nonpalpable Breast Lesions (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:
- Charcotrace Inj. CI brief — competitive landscape report
- Charcotrace Inj. updates RSS · CI watch RSS
- Hanlim Pharm. Co., Ltd. portfolio CI
Frequently asked questions about Charcotrace Inj.
What is Charcotrace Inj.?
How does Charcotrace Inj. work?
What is Charcotrace Inj. used for?
Who makes Charcotrace Inj.?
Is Charcotrace Inj. also known as anything else?
What development phase is Charcotrace Inj. in?
Related
- Manufacturer: Hanlim Pharm. Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Neurology / Diagnostic Imaging
- Indication: Drugs for Diagnostic imaging of neurological lesions and neural pathways
- Also known as: Charcotrace Injection(Activated Charcoal 40mg/1ml)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing