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MY008211A tablets
MY008211A tablets is a Small molecule drug developed by Wuhan Createrna Science and Technology Co., Ltd. It is currently in Phase 3 development. Also known as: no other name, MY008211A, no name.
MY008211A tablets' mechanism is unknown.
MY008211A tablets are a small molecule medication being studied in clinical trials for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and IgA Nephropathy (IgAN). The exact mechanism of action of MY008211A tablets is currently unknown.
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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 | MY008211A tablets |
|---|---|
| Also known as | no other name, MY008211A, no name |
| Sponsor | Wuhan Createrna Science and Technology Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 3 |
Mechanism of action
No information is available on the mechanism of action of MY008211A tablets.
Approved indications
Common side effects
Key clinical trials
- A Study of MY008211A in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) (PHASE2)
- Study of Safety and Efficacy of MY008211A in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) (PHASE2)
- Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment (PHASE3)
- Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy (PHASE3)
- Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria (PHASE2, PHASE3)
- Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) (PHASE2)
- To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects (PHASE1)
- A Study of Single-dose MY008211A in Healthy Adults (PHASE1)
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:
- MY008211A tablets CI brief — competitive landscape report
- MY008211A tablets updates RSS · CI watch RSS
- Wuhan Createrna Science and Technology Co., Ltd portfolio CI
Frequently asked questions about MY008211A tablets
What is MY008211A tablets?
How does MY008211A tablets work?
Who makes MY008211A tablets?
Is MY008211A tablets also known as anything else?
What development phase is MY008211A tablets in?
Related
- Manufacturer: Wuhan Createrna Science and Technology Co., Ltd — full pipeline
- Also known as: no other name, MY008211A, no name
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing