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Stanate
Stanate is a Small molecule drug developed by InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company. It is currently in Phase 2 development.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Stanate |
|---|---|
| Sponsor | InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Follow up Study of Patients Having Participated in Clinical Trial 64,185-204
- Stannsoporfin With Light Therapy for Newborn Babies With Jaundice (PHASE2)
- A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia (PHASE2)
- Efficacy and Safety of Stannsoporfin in Neonates (PHASE3)
- Compassionate Use of Stanate (TM) [Stannsoporfin]
- Safety and Pharmacology of Stanate (PHASE2)
- Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
- Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)
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:
- Stanate CI brief — competitive landscape report
- Stanate updates RSS · CI watch RSS
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company portfolio CI
Frequently asked questions about Stanate
What is Stanate?
Who makes Stanate?
What development phase is Stanate in?
Related
- Manufacturer: InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing