Last reviewed 2026-05-30 · How we verify

Terpinen-4-ol

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

Terpinen-4-ol is a Small molecule drug developed by BioTissue Holdings, Inc. It is currently in Phase 1 development. Also known as: T4O.

Terpinen-4-ol is a small molecule with the chemical formula C10H18O, obtained as an extract from the leaves, branches, and bark of Melaleuca alternifolia Cheel. It is a primary constituent of tea tree oil and has been studied in clinical trials for various conditions, including Seborrheic Blepharitis, Knee Osteoarthritis, and Asthma.

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	Terpinen-4-ol
Also known as	T4O
Sponsor	BioTissue Holdings, Inc
Modality	Small molecule
Phase	Phase 1

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:

Terpinen-4-ol CI brief — competitive landscape report
Terpinen-4-ol updates RSS · CI watch RSS
BioTissue Holdings, Inc portfolio CI

Frequently asked questions about Terpinen-4-ol

What is Terpinen-4-ol?

Terpinen-4-ol is a Small molecule drug developed by BioTissue Holdings, Inc.

Who makes Terpinen-4-ol?

Terpinen-4-ol is developed by BioTissue Holdings, Inc (see full BioTissue Holdings, Inc pipeline at /company/biotissue-holdings-inc).

Is Terpinen-4-ol also known as anything else?

Terpinen-4-ol is also known as T4O.

What development phase is Terpinen-4-ol in?

Terpinen-4-ol is in Phase 1.

Manufacturer: BioTissue Holdings, Inc — full pipeline
Also known as: T4O

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