Last reviewed 2026-06-01 · How we verify

ALK tree AIT 1 DU

ALK-Abelló A/S · Phase 2 active Biologic Under review

ALK tree AIT 1 DU is a ALK inhibitor Biologic drug developed by ALK-Abelló A/S. It is currently in Phase 2 development for Non-small cell lung cancer with ALK rearrangement.

ALK tree AIT 1 DU is a targeted therapy that works by inhibiting the anaplastic lymphoma kinase (ALK) protein.

ALK tree AIT 1 DU is a treatment option for Birch Pollen Allergy, as it has been studied in a clinical trial. The treatment is part of a tablet-based allergy immunotherapy product developed by ALK-Abelló A/S.

Likelihood of approval

13.3% 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).
Oncology Phase 2 attrition -2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.

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 1 DU
Sponsor	ALK-Abelló A/S
Drug class	ALK inhibitor
Target	ALK
Modality	Biologic
Therapeutic area	Oncology
Phase	Phase 2

Mechanism of action

ALK tree AIT 1 DU is a small molecule inhibitor that specifically targets the ALK protein, which is involved in the development and progression of certain types of cancer. By inhibiting ALK, the drug aims to slow down or stop the growth of cancer cells.

Approved indications

Non-small cell lung cancer with ALK rearrangement

Common side effects

Diarrhea
Nausea
Vomiting
Fatigue
Muscle pain

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 1 DU CI brief — competitive landscape report
ALK tree AIT 1 DU updates RSS · CI watch RSS
ALK-Abelló A/S portfolio CI

Frequently asked questions about ALK tree AIT 1 DU

What is ALK tree AIT 1 DU?

ALK tree AIT 1 DU is a ALK inhibitor drug developed by ALK-Abelló A/S, indicated for Non-small cell lung cancer with ALK rearrangement.

How does ALK tree AIT 1 DU work?

ALK tree AIT 1 DU is a targeted therapy that works by inhibiting the anaplastic lymphoma kinase (ALK) protein.

What is ALK tree AIT 1 DU used for?

ALK tree AIT 1 DU is indicated for Non-small cell lung cancer with ALK rearrangement.

Who makes ALK tree AIT 1 DU?

ALK tree AIT 1 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 1 DU in?

ALK tree AIT 1 DU belongs to the ALK inhibitor class. See all ALK inhibitor drugs at /class/alk-inhibitor.

What development phase is ALK tree AIT 1 DU in?

ALK tree AIT 1 DU is in Phase 2.

What are the side effects of ALK tree AIT 1 DU?

Common side effects of ALK tree AIT 1 DU include Diarrhea, Nausea, Vomiting, Fatigue, Muscle pain.

What does ALK tree AIT 1 DU target?

ALK tree AIT 1 DU targets ALK and is a ALK inhibitor.

Drug class: All ALK inhibitor drugs
Target: All drugs targeting ALK
Manufacturer: ALK-Abelló A/S — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer with ALK rearrangement

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