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Nuvastatic
Nuvastatic is a Small molecule drug developed by Natureceuticals Sdn Bhd. It is currently in Phase 1 development. Also known as: C5OSEW5050ESA, Lanctos 75 standardized Orthosiphon Stamineus Extract.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Nuvastatic |
|---|---|
| Also known as | C5OSEW5050ESA, Lanctos 75 standardized Orthosiphon Stamineus Extract |
| Sponsor | Natureceuticals Sdn Bhd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Study to Evaluate Clinical Efficacy and Safety of Nuvastatic™ - C5OSEW5050ESA in Diabetic Retinopathy. (PHASE1, PHASE2)
- Evaluation of Clinical Efficacy and Safety of Nuvastatic in Cancer Asthenia (PHASE2, PHASE3)
- To Evaluate Safety and Efficacy of Nuvastatic as an Immunomodulator Adjuvant Therapy in COVID-19 Patients. (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:
- Nuvastatic CI brief — competitive landscape report
- Nuvastatic updates RSS · CI watch RSS
- Natureceuticals Sdn Bhd portfolio CI
Frequently asked questions about Nuvastatic
What is Nuvastatic?
Who makes Nuvastatic?
Is Nuvastatic also known as anything else?
What development phase is Nuvastatic in?
Related
- Manufacturer: Natureceuticals Sdn Bhd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: C5OSEW5050ESA, Lanctos 75 standardized Orthosiphon Stamineus Extract
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing