Last reviewed 2026-05-26 · How we verify

TO-O-1001

Theratocular Biotek Co. · Phase 1 active Small molecule ✓ Verified May 2026

TO-O-1001 is a Small molecule drug developed by Theratocular Biotek Co.. It is currently in Phase 1 development.

TO-O-1001 is an eye drop being investigated for its effect on intraocular pressure (IOP) in patients with Open Angle Glaucoma or Ocular Hypertension. The study, NCT05456724, is a first-in-human, double-blind, randomized trial comparing TO-O-1001 to a placebo in healthy subjects and patients with these conditions.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	TO-O-1001
Sponsor	Theratocular Biotek Co.
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Investigate the Effect of IOP-lowering With TO-O-1001 Eye Drops in Healthy Subjects and in Patients With Open-Angle Glaucoma or Ocular Hypertension (PHASE1, PHASE2)

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:

TO-O-1001 CI brief — competitive landscape report
TO-O-1001 updates RSS · CI watch RSS
Theratocular Biotek Co. portfolio CI

Frequently asked questions about TO-O-1001

What is TO-O-1001?

TO-O-1001 is a Small molecule drug developed by Theratocular Biotek Co..

Who makes TO-O-1001?

TO-O-1001 is developed by Theratocular Biotek Co. (see full Theratocular Biotek Co. pipeline at /company/theratocular-biotek-co).

What development phase is TO-O-1001 in?

TO-O-1001 is in Phase 1.

Manufacturer: Theratocular Biotek Co. — full pipeline

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