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SPARC1316 Dose 1
SPARC1316 Dose 1 is a Small molecule drug developed by Sun Pharma Advanced Research Company Limited. It is currently in Phase 1 development.
SPARC1316 Dose 1 is a small molecule intervention being studied for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with asthma. The study, which was completed in 2016, compared SPARC1316 Dose 1 to a placebo and a second dose of SPARC1316.
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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 | SPARC1316 Dose 1 |
|---|---|
| Sponsor | Sun Pharma Advanced Research Company Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
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:
- SPARC1316 Dose 1 CI brief — competitive landscape report
- SPARC1316 Dose 1 updates RSS · CI watch RSS
- Sun Pharma Advanced Research Company Limited portfolio CI
Frequently asked questions about SPARC1316 Dose 1
What is SPARC1316 Dose 1?
Who makes SPARC1316 Dose 1?
What development phase is SPARC1316 Dose 1 in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing