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Dithiosteine (ERDOSTEINE)
Dithiosteine (generic name: ERDOSTEINE) is a erdosteine drug. It is currently in Phase 3 development for Accidental poisoning by lead and its compounds and fumes, Mercury Toxicity.
Erdosteine works by binding to heavy metals and facilitating their excretion from the body.
Dithiosteine is a small molecule with an expectorant mechanism. It is also known by the synonyms ERDOSTEINA, ERDOSTEINE, and others.
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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 | ERDOSTEINE |
|---|---|
| Drug class | erdosteine |
| Modality | Small molecule |
| Therapeutic area | Nephrology |
| Phase | Phase 3 |
Mechanism of action
Imagine Erdosteine as a special kind of 'mop' that helps clean up heavy metals like lead and mercury from your body. It binds to these metals and helps your body get rid of them, which can prevent damage to your organs and tissues.
Approved indications
- Accidental poisoning by lead and its compounds and fumes
- Mercury Toxicity
Common side effects
- Pneumonia
Key clinical trials
- Immuno-inflammatory Response of Erdosteine in COPD (NA)
- Erdosteine in the Treatment of Nonalcoholic Fatty Liver Disease (PHASE1,PHASE2)
- Study of Late Boost Strategies for HIV-uninfected Participants From Protocol RV 144 (PHASE2)
- Long-term Immunogenicity of the HIV gp120-NefTat/AS01B Vaccine (GSK SB732461) (PHASE1)
- Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) (PHASE4)
- Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial
- Drug Interaction Study Between Erdosteine and Bepotastine Besilate in Healthy Adult Volunteers (PHASE1)
- The Efficacy and Safety of Erdosteine in Chronic Obstructive Pulmonary Disease (COPD) (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:
- Dithiosteine CI brief — competitive landscape report
- Dithiosteine updates RSS · CI watch RSS
Frequently asked questions about Dithiosteine
What is Dithiosteine?
How does Dithiosteine work?
What is Dithiosteine used for?
What is the generic name of Dithiosteine?
What drug class is Dithiosteine in?
What development phase is Dithiosteine in?
What are the side effects of Dithiosteine?
Related
- Drug class: All erdosteine drugs
- Therapeutic area: All drugs in Nephrology
- Indication: Drugs for Accidental poisoning by lead and its compounds and fumes
- Indication: Drugs for Mercury Toxicity
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing