Last reviewed 2026-05-23 · How we verify

Mitizax

Abbott · Phase 3 active Small molecule ✓ Verified May 2026

Mitizax is a Small molecule drug developed by Abbott. It is currently in Phase 3 development. Also known as: ALK HDM tablet, allergen extract.

Mitizax is a medication being studied for the treatment of allergy, asthma, and rhinitis. It is being investigated in a 60-day treatment period as part of a randomized, double-blind, placebo-controlled study.

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 name	Mitizax
Also known as	ALK HDM tablet, allergen extract
Sponsor	Abbott
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 3

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma (PHASE3)

Primary sources

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

Source	Used for
ClinicalTrials.gov	Trial 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:

Mitizax CI brief — competitive landscape report
Mitizax updates RSS · CI watch RSS
Abbott portfolio CI

Frequently asked questions about Mitizax

What is Mitizax?

Mitizax is a Small molecule drug developed by Abbott.

Who makes Mitizax?

Mitizax is developed by Abbott (see full Abbott pipeline at /company/abbott).

Is Mitizax also known as anything else?

Mitizax is also known as ALK HDM tablet, allergen extract.

What development phase is Mitizax in?

Mitizax is in Phase 3.

Manufacturer: Abbott — full pipeline
Therapeutic area: All drugs in Other
Also known as: ALK HDM tablet, allergen extract

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