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Acarizax

University Hospital, Montpellier · Phase 3 active Small molecule ✓ Verified Jun 2026

Acarizax is a Small molecule drug developed by University Hospital, Montpellier. It is currently in Phase 3 development.

Acarizax is a sublingual allergy immunological tablet used to treat conditions such as allergic rhinitis, allergic rhinoconjunctivitis, and allergic asthma due to house dust mites. It is specifically indicated for allergic reactions caused by the droppings of house dust mites, which contain potent digestive enzymes that can trigger symptoms like wheezing.

Likelihood of approval
58.3% vs 58.3% industry baseline
If approved by FDA: likely 2028–2030
Steps remaining: NDA/BLA submission
Confidence: High
Why this estimate
  • Baseline phase 3 → approval rate +58.3pp
    Industry-wide phase 3 drugs reach approval ~58.3% 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 2028–2030
EMA EU 2029–2031 +0.7 yr
MHRA GB 2029–2031 +0.7 yr
Health Canada CA 2029–2032 +0.9 yr
TGA AU 2029–2032 +1.2 yr
PMDA JP 2029–2032 +1.5 yr
NMPA CN 2030–2033 +2.3 yr
MFDS KR 2029–2032 +1.4 yr
CDSCO IN 2029–2033 +1.8 yr
ANVISA BR 2030–2033 +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 nameAcarizax
SponsorUniversity Hospital, Montpellier
ModalitySmall molecule
Therapeutic areaOther
PhasePhase 3

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 Acarizax

What is Acarizax?

Acarizax is a Small molecule drug developed by University Hospital, Montpellier.

Who makes Acarizax?

Acarizax is developed by University Hospital, Montpellier (see full University Hospital, Montpellier pipeline at /company/university-hospital-montpellier).

What development phase is Acarizax in?

Acarizax is in Phase 3.

Related

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