Last reviewed 2026-05-26 · How we verify

TLC-1180 Oral Solution

OrsoBio, Inc · Phase 1 active Small molecule ✓ Verified May 2026

TLC-1180 Oral Solution is a Small molecule drug developed by OrsoBio, Inc. It is currently in Phase 1 development.

TLC-1180 Oral Solution is a vaccine component that induces an immune response. It is being studied in a Phase 1 clinical trial to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants.

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	TLC-1180 Oral Solution
Sponsor	OrsoBio, Inc
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 Evaluate Single and Multiple Doses of TLC-1180 in Healthy Subjects (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:

TLC-1180 Oral Solution CI brief — competitive landscape report
TLC-1180 Oral Solution updates RSS · CI watch RSS
OrsoBio, Inc portfolio CI

Frequently asked questions about TLC-1180 Oral Solution

What is TLC-1180 Oral Solution?

TLC-1180 Oral Solution is a Small molecule drug developed by OrsoBio, Inc.

Who makes TLC-1180 Oral Solution?

TLC-1180 Oral Solution is developed by OrsoBio, Inc (see full OrsoBio, Inc pipeline at /company/orsobio-inc).

What development phase is TLC-1180 Oral Solution in?

TLC-1180 Oral Solution is in Phase 1.

Manufacturer: OrsoBio, Inc — full pipeline

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