Last reviewed 2026-05-31 · How we verify

OTX-101 0.05%

Sun Pharmaceutical Industries Limited · Phase 2 active Small molecule ✓ Verified May 2026

OTX-101 0.05% is a Small molecule drug developed by Sun Pharmaceutical Industries Limited. It is currently in Phase 2 development.

OTX-101 is a small molecule being studied as a potential treatment for Keratoconjunctivitis Sicca and Dry Eye Disease. It is being evaluated in a phase 2/3 clinical trial in various concentrations, including 0.05% and 0.09%, compared to a vehicle control.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	OTX-101 0.05%
Sponsor	Sun Pharmaceutical Industries Limited
Modality	Small molecule
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (PHASE2, 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:

OTX-101 0.05% CI brief — competitive landscape report
OTX-101 0.05% updates RSS · CI watch RSS
Sun Pharmaceutical Industries Limited portfolio CI

Frequently asked questions about OTX-101 0.05%

What is OTX-101 0.05%?

OTX-101 0.05% is a Small molecule drug developed by Sun Pharmaceutical Industries Limited.

Who makes OTX-101 0.05%?

OTX-101 0.05% is developed by Sun Pharmaceutical Industries Limited (see full Sun Pharmaceutical Industries Limited pipeline at /company/sun-pharmaceutical-industries-limited).

What development phase is OTX-101 0.05% in?

OTX-101 0.05% is in Phase 2.

Manufacturer: Sun Pharmaceutical Industries Limited — full pipeline

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