Last reviewed 2026-05-31 · How we verify

ALK tree AIT 4 DU

ALK-Abelló A/S · Phase 2 active Biologic ✓ Verified May 2026 Quality 35/100

ALK tree AIT 4 DU is a Allergen immunotherapy Biologic drug developed by ALK-Abelló A/S. It is currently in Phase 2 development.

Allergen immunotherapy designed to modulate immune response to specific allergens through controlled exposure.

ALK tree AIT is an allergy immunotherapy tablet used to treat Birch Pollen Allergy. It is available in different doses, including 0.5 DU, 1 DU, and 2 DU, as evaluated in a completed clinical trial.

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 name	ALK tree AIT 4 DU
Sponsor	ALK-Abelló A/S
Drug class	Allergen immunotherapy
Modality	Biologic
Phase	Phase 2

Mechanism of action

The product likely works through allergen-specific immunotherapy mechanisms, gradually desensitizing the immune system to specific allergens. This approach typically involves inducing immune tolerance and shifting the balance from allergic Th2 responses toward regulatory T-cell responses.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet (PHASE2)

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:

ALK tree AIT 4 DU CI brief — competitive landscape report
ALK tree AIT 4 DU updates RSS · CI watch RSS
ALK-Abelló A/S portfolio CI

Frequently asked questions about ALK tree AIT 4 DU

What is ALK tree AIT 4 DU?

ALK tree AIT 4 DU is a Allergen immunotherapy drug developed by ALK-Abelló A/S.

How does ALK tree AIT 4 DU work?

Allergen immunotherapy designed to modulate immune response to specific allergens through controlled exposure.

Who makes ALK tree AIT 4 DU?

ALK tree AIT 4 DU is developed by ALK-Abelló A/S (see full ALK-Abelló A/S pipeline at /company/alk-abell-a-s).

What drug class is ALK tree AIT 4 DU in?

ALK tree AIT 4 DU belongs to the Allergen immunotherapy class. See all Allergen immunotherapy drugs at /class/allergen-immunotherapy.

What development phase is ALK tree AIT 4 DU in?

ALK tree AIT 4 DU is in Phase 2.

Drug class: All Allergen immunotherapy drugs
Manufacturer: ALK-Abelló A/S — full pipeline

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