Last reviewed 2026-05-25 · How we verify

Falmonox (TECLOZAN)

Phase 2 active Small molecule ✓ Verified May 2026

Falmonox (generic name: TECLOZAN) is a teclozan drug. It is currently in Phase 2 development.

Falmonox works by inhibiting a specific enzyme or pathway, although the exact details of this process are not well understood.

Falmonox is a small molecule with the synonyms FALMONOX, NSC-107433, TECLOZAN, and WIN 13,146.

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	TECLOZAN
Drug class	teclozan
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a key fitting into a lock. Falmonox is like a key that blocks a specific lock, preventing a certain process from happening. This can help to treat a variety of conditions, but more research is needed to understand exactly how it works and what benefits it can provide.

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:

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

Frequently asked questions about Falmonox

What is Falmonox?

Falmonox (TECLOZAN) is a teclozan drug.

How does Falmonox work?

Falmonox works by inhibiting a specific enzyme or pathway, although the exact details of this process are not well understood.

What is the generic name of Falmonox?

TECLOZAN is the generic (nonproprietary) name of Falmonox.

What drug class is Falmonox in?

Falmonox belongs to the teclozan class. See all teclozan drugs at /class/teclozan.

What development phase is Falmonox in?

Falmonox is in Phase 2.

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

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