Last reviewed 2026-05-22 · How we verify

SPARC0913

Sun Pharma Advanced Research Company Limited · Phase 3 active Small molecule Under review

SPARC0913 is a Small molecule drug developed by Sun Pharma Advanced Research Company Limited. It is currently in Phase 3 development for Phase 3 clinical trials are ongoing for SPARC0913 in various indications..

SPARC0913 is a small molecule that targets the molecular target.

SPARC0913 is a treatment being studied for Open Angle Glaucoma and Ocular Hypertension. The safety of SPARC0913 in these conditions was evaluated in a completed clinical trial (NCT00945958).

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	SPARC0913
Sponsor	Sun Pharma Advanced Research Company Limited
Modality	Small molecule
Phase	Phase 3

Mechanism of action

The exact mechanism of action of SPARC0913 is not well understood, but it is believed to work by interacting with the molecular target, leading to a specific therapeutic effect.

Approved indications

Phase 3 clinical trials are ongoing for SPARC0913 in various indications.

Common side effects

Unknown

Key clinical trials

Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension (PHASE3)

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:

SPARC0913 CI brief — competitive landscape report
SPARC0913 updates RSS · CI watch RSS
Sun Pharma Advanced Research Company Limited portfolio CI

Frequently asked questions about SPARC0913

What is SPARC0913?

SPARC0913 is a Small molecule drug developed by Sun Pharma Advanced Research Company Limited, indicated for Phase 3 clinical trials are ongoing for SPARC0913 in various indications..

How does SPARC0913 work?

SPARC0913 is a small molecule that targets the molecular target.

What is SPARC0913 used for?

SPARC0913 is indicated for Phase 3 clinical trials are ongoing for SPARC0913 in various indications..

Who makes SPARC0913?

SPARC0913 is developed by Sun Pharma Advanced Research Company Limited (see full Sun Pharma Advanced Research Company Limited pipeline at /company/sun-pharma-advanced-research-company-limited).

What development phase is SPARC0913 in?

SPARC0913 is in Phase 3.

What are the side effects of SPARC0913?

Common side effects of SPARC0913 include Unknown.

Manufacturer: Sun Pharma Advanced Research Company Limited — full pipeline
Indication: Drugs for Phase 3 clinical trials are ongoing for SPARC0913 in various indications.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing