Last reviewed · How we verify

Bisguadine (ALEXIDINE)

Phase 2 active Small molecule ✓ Verified May 2026

Bisguadine (generic name: ALEXIDINE) is a alexidine drug. It is currently in Phase 2 development.

Bisguadine works by inhibiting phosphatidylglycerophosphatase and protein-tyrosine phosphatase 1, which are enzymes involved in cellular signaling pathways.

Bisguadine is a small molecule with the synonyms ALEXIDINA, ALEXIDINE, COMPOUND 904, and STERWIN 904. Its modality is classified as a small molecule.

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 nameALEXIDINE
Drug classalexidine
TargetPhosphatidylglycerophosphatase and protein-tyrosine phosphatase 1, Toll-like receptor 9, Beta-lactamase
ModalitySmall molecule
Therapeutic areaMetabolic
PhasePhase 2

Mechanism of action

Think of it like a key that unlocks a door. In this case, the key is Bisguadine, and the door is a cellular pathway that's locked by the phosphatase enzymes. By inhibiting these enzymes, Bisguadine can help unlock the pathway and allow the cell to function properly.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

Competitive intelligence

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

Frequently asked questions about Bisguadine

What is Bisguadine?

Bisguadine (ALEXIDINE) is a alexidine drug.

How does Bisguadine work?

Bisguadine works by inhibiting phosphatidylglycerophosphatase and protein-tyrosine phosphatase 1, which are enzymes involved in cellular signaling pathways.

What is the generic name of Bisguadine?

ALEXIDINE is the generic (nonproprietary) name of Bisguadine.

What drug class is Bisguadine in?

Bisguadine belongs to the alexidine class. See all alexidine drugs at /class/alexidine.

What development phase is Bisguadine in?

Bisguadine is in Phase 2.

What does Bisguadine target?

Bisguadine targets Phosphatidylglycerophosphatase and protein-tyrosine phosphatase 1, Toll-like receptor 9, Beta-lactamase and is a alexidine.

Related

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