Last reviewed 2026-05-20 · How we verify

Noxyflex S (NOXYTIOLIN)

Phase 2 active Small molecule ✓ Verified May 2026

Noxyflex S (generic name: NOXYTIOLIN) is a noxytiolin drug. It is currently in Phase 2 development for Infective cystitis.

Noxytiolin works by inhibiting bacterial growth and replication.

Noxyflex S is a small molecule. It is also known by other names, including Noxitiolina, Noxythiolin, and various other synonyms.

Likelihood of approval

17.3% 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).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.

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	NOXYTIOLIN
Drug class	noxytiolin
Modality	Small molecule
Therapeutic area	Infectious Disease
Phase	Phase 2

Mechanism of action

Imagine your body's cells are under attack by bad bacteria. Noxytiolin helps stop these bacteria from multiplying and taking over, allowing your body's natural defenses to fight back and heal the infection.

Approved indications

Infective cystitis

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:

Noxyflex S CI brief — competitive landscape report
Noxyflex S updates RSS · CI watch RSS

Frequently asked questions about Noxyflex S

What is Noxyflex S?

Noxyflex S (NOXYTIOLIN) is a noxytiolin drug, indicated for Infective cystitis.

How does Noxyflex S work?

Noxytiolin works by inhibiting bacterial growth and replication.

What is Noxyflex S used for?

Noxyflex S is indicated for Infective cystitis.

What is the generic name of Noxyflex S?

NOXYTIOLIN is the generic (nonproprietary) name of Noxyflex S.

What drug class is Noxyflex S in?

Noxyflex S belongs to the noxytiolin class. See all noxytiolin drugs at /class/noxytiolin.

What development phase is Noxyflex S in?

Noxyflex S is in Phase 2.

Drug class: All noxytiolin drugs
Therapeutic area: All drugs in Infectious Disease
Indication: Drugs for Infective cystitis

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