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SPARC001 type I
SPARC001 type I is a Small molecule drug developed by Sun Pharma Advanced Research Company Limited. It is currently in Phase 1 development.
SPARC001 type I is a hydrolytic enzyme that targets Synaptosomal-associated protein 25 (SNAP-25). It was studied in a bioavailability study involving healthy adult volunteers.
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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 | SPARC001 type I |
|---|---|
| Sponsor | Sun Pharma Advanced Research Company Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers (PHASE1)
- Bioavailability Study of SPARC001 (Study 2) in Healthy Adult Volunteers (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:
- SPARC001 type I CI brief — competitive landscape report
- SPARC001 type I updates RSS · CI watch RSS
- Sun Pharma Advanced Research Company Limited portfolio CI
Frequently asked questions about SPARC001 type I
What is SPARC001 type I?
Who makes SPARC001 type I?
What development phase is SPARC001 type I in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing