Last reviewed 2026-05-25 · How we verify

Bactacine (XIBORNOL)

Phase 2 active Small molecule ✓ Verified May 2026

Bactacine (generic name: XIBORNOL) is a xibornol drug. It is currently in Phase 2 development.

Bactacine works by interacting with a specific biological target to produce its therapeutic effect.

Bactacine is a small molecule with the synonyms 6-ISOBORNYL-3,4-XYLENOL, XIBORNOL, and XIBORNOL.

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	XIBORNOL
Drug class	xibornol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Unfortunately, the exact way Bactacine works is not well understood, but it is thought to affect the body's response to certain stimuli. This can lead to changes in how the body functions, which may help to treat certain conditions. However, more research is needed to fully understand its mechanism of action.

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:

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

Frequently asked questions about Bactacine

What is Bactacine?

Bactacine (XIBORNOL) is a xibornol drug.

How does Bactacine work?

Bactacine works by interacting with a specific biological target to produce its therapeutic effect.

What is the generic name of Bactacine?

XIBORNOL is the generic (nonproprietary) name of Bactacine.

What drug class is Bactacine in?

Bactacine belongs to the xibornol class. See all xibornol drugs at /class/xibornol.

What development phase is Bactacine in?

Bactacine is in Phase 2.

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

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