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Methylthioninium
Methylthioninium is a Small molecule drug developed by Shandong Cancer Hospital and Institute. It is currently in Phase 3 development for Methemoglobinemia.
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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 | Methylthioninium |
|---|---|
| Sponsor | Shandong Cancer Hospital and Institute |
| Target | Microtubule-associated protein tau, Amine oxidase [flavin-containing] A, Amine oxidase [flavin-containing] B |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
- Methemoglobinemia
Common side effects
Key clinical trials
- Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection (PHASE1, PHASE2)
- Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections (PHASE3)
- Technical Feasibility Evaluation of Mucosal Staining During Colon Capsule Endoscopy (CCE) Procedure in Colorectal Cancer (CRC) High Risk Population, When Using MB-MMX (NA)
- The Effect of Combination Therapy of Oral MB and PRP-FG in Patients With Non-healing Diabetic Foot Ulcer (EARLY_PHASE1)
- Open-Label Study of Leuco-methylthioninium Bis(Hydromethanesulfonate) (LMTM) in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD) (PHASE3)
- MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN) (PHASE2)
- Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis (PHASE4)
- Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria (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:
- Methylthioninium CI brief — competitive landscape report
- Methylthioninium updates RSS · CI watch RSS
- Shandong Cancer Hospital and Institute portfolio CI
Frequently asked questions about Methylthioninium
What is Methylthioninium?
What is Methylthioninium used for?
Who makes Methylthioninium?
What development phase is Methylthioninium in?
What does Methylthioninium target?
Related
- Target: All drugs targeting Microtubule-associated protein tau, Amine oxidase [flavin-containing] A, Amine oxidase [flavin-containing] B
- Manufacturer: Shandong Cancer Hospital and Institute — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Methemoglobinemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing