Last reviewed 2026-05-27 · How we verify

Thoragol (BIBENZONIUM)

Phase 2 active Small molecule ✓ Verified May 2026

Thoragol (generic name: BIBENZONIUM) is a bibenzonium drug. It is currently in Phase 2 development.

Thoragol is believed to work by interacting with specific biological pathways, although the exact mechanism is unknown.

Thoragol is a small molecule modality. It is also known by the synonyms BIBENZONIUM BROMIDE, BROMURE DE BIBENZONIUM, BROMURO DE BIBENZONIO, and SODOBEX.

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	BIBENZONIUM
Drug class	bibenzonium
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells are like a city with many different streets and buildings. Thoragol is thought to work by finding and interacting with specific 'street signs' or 'buildings' in the city, which helps to regulate the city's functions and keep everything running smoothly. However, the exact 'street signs' or 'buildings' that Thoragol interacts with are not yet fully understood.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Thoragol CI brief — competitive landscape report
Thoragol updates RSS · CI watch RSS

Frequently asked questions about Thoragol

What is Thoragol?

Thoragol (BIBENZONIUM) is a bibenzonium drug.

How does Thoragol work?

Thoragol is believed to work by interacting with specific biological pathways, although the exact mechanism is unknown.

What is the generic name of Thoragol?

BIBENZONIUM is the generic (nonproprietary) name of Thoragol.

What drug class is Thoragol in?

Thoragol belongs to the bibenzonium class. See all bibenzonium drugs at /class/bibenzonium.

What development phase is Thoragol in?

Thoragol is in Phase 2.

Drug class: All bibenzonium drugs
Therapeutic area: All drugs in Other

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