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Biaxin®

Teva Pharmaceuticals USA · Phase 1 active Small molecule ✓ Verified Jun 2026

Biaxin® is a Small molecule drug developed by Teva Pharmaceuticals USA. It is currently in Phase 1 development.

Biaxin (clarithromycin) is a small molecule inhibitor of the bacterial 70S ribosome, used to treat conditions such as lower respiratory tract infections, pneumonia, and acute exacerbation of chronic obstructive airways disease. It is indicated for use in various clinical trials, including those for lower respiratory tract infections, healthy individuals, pneumonia, acute exacerbation of chronic obstructive airways disease, and multiple myeloma.

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 nameBiaxin®
SponsorTeva Pharmaceuticals USA
ModalitySmall molecule
PhasePhase 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:

Frequently asked questions about Biaxin®

What is Biaxin®?

Biaxin® is a Small molecule drug developed by Teva Pharmaceuticals USA.

Who makes Biaxin®?

Biaxin® is developed by Teva Pharmaceuticals USA (see full Teva Pharmaceuticals USA pipeline at /company/teva-pharmaceuticals-usa).

What development phase is Biaxin® in?

Biaxin® is in Phase 1.

Related

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