Drugs / Acarizax
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | ACARIZAX | allergic rhinitis | 2024-01-25 | “the European regulatory filing for ACARIZAX ® (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review” alk.net ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT07013123 | Jul 2025 → Aug 2029 expected | asthma, house allergic alveolitis | University Hospital, Montpellier | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT06509243 Comparator | Feb 2023 → Mar 2024 | atopic eczema | Medical University of Silesia | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2026-08-14 | ALK-Abelló A/S | Regulatory ALK’s tree pollen and house dust mite tablets now recommended by NICE for paediatric treatment in the UK health system alk.net ↗
ITULAZAX ® is recommended for children aged 5 to 17 with birch pollen allergy and ACARIZAX ® for children aged 5 to 11 with house dust mite allergy, making both tablets available to eligible children through the National Health Service (NHS). |
| 2025-03-07 | ALK-Abelló A/S | Regulatory ACARIZAX® approved in Canada for treatment of young children alk.net ↗
ALK ( ALKB:DC / OMX: ALK B ) today announced that Health Canada has approved ALK’s ACARIZAX ® tablet for use in children, aged five to 11, with house dust mite (HDM) allergy. |
| 2025-01-30 | ALK-Abelló A/S | Regulatory ALK’s house dust mite tablet (ACARIZAX®) now recommended by NICE for use in the UK health system alk.net ↗
ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced that the National Institute for Health and Care Excellence (NICE) has recommended the use of ACARIZAX ® for the treatment of persistent, moderate to severe house dust mite allergic rhinitis in adults and adolescents. |
| 2024-12-12 | ALK-Abelló A/S | Regulatory ACARIZAX® approved in Europe for treatment of young children alk.net ↗
Today’s approval marks an important step forward for our ability to transform the medical treatment of children with allergies, as well as for ALK’s long-term growth ambitions |
| 2024-11-27 | ALK-Abelló A/S | Results ALK’s pivotal phase 3 trial in children published in reputable scientific journal alk.net ↗
This trial confirms earlier results reported in ALK’s adult house dust mite tablet trials and was conducted in accordance with ALK’s clinical development strategy to focus on children and to target allergies at an early stage in life. |
| 2024-01-25 | ALK-Abelló A/S | Regulatory ALK’s European registration application for house dust mite SLIT-tablet in young children accepted for review alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKBLF ) today announced that the European regulatory filing for ACARIZAX ® (house dust mite sublingual immunotherapy tablet) in young children has been accepted for review by the relevant health authorities via a type II variation. |
| 2023-06-08 | ALK-Abelló A/S | Results Large Phase 3 clinical trial successfully meets primary endpoint, confirming the potential of ALK’s house dust mite tablet in young children alk.net ↗
The trial achieved its primary endpoint with an improvement of 22% in the total combined rhinitis score (TCRS) compared to placebo treated patients. |
| 2023-02-03 | ALK-Abelló A/S | Regulatory Regulatory filing for house dust mite allergy tablet accepted for review in China alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKBLF ) today announced that its Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (AIT) tablet has been accepted for review by the National Medical Products Administration (NMPA) in China. |
| 2022-03-03 | ALK-Abelló A/S | Regulatory Clinical trial waiver in China opens door to 2022 registration filing for ALK’s dust mite allergy tablet alk.net ↗
A registration trial waiver from the Chinese authorities now allows ALK to submit a Biologics Licence Application (BLA) in China without finalising the local Phase III trial. |
| 2019-02-26 | ALK-Abelló A/S | Results New data shows ALK’s house dust mite SLIT-tablet significantly improves quality of sleep for allergic rhinitis patients alk.net ↗
ALK has released new analysis of clinical trial data showing that its sublingual allergy immunotherapy (SLIT) tablet for the treatment of house dust mite (HDM)-related allergy can significantly improve quality of sleep for allergic rhinitis patients. |
| 2018-02-16 | ALK-Abelló A/S | Regulatory ALK’s partner, Torii, gains paediatric approval for the house dust mite SLIT-tablet in Japan alk.net ↗
Since MITICURE™ is already on the market in Japan, no new launch is necessary and the product becomes available for paediatric use with immediate effect. |
| 2017-11-30 | ALK-Abelló A/S | Regulatory ALK secures pricing and reimbursement for ACARIZAX® in France alk.net ↗ |
| 2017-05-04 | ALK-Abelló A/S | Regulatory ALK's HDM SLIT-tablet, ACARIZAX®, approved in Canada alk.net ↗
Copenhagen, 2017-05-04 21:07 CEST (GLOBE NEWSWIRE) -- ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet, ACARIZAX ® , has been approved in Canada. |
| 2017-04-16 | ALK-Abelló A/S | Regulatory ACARIZAX® approved in Europe for use in adolescent patients with house dust mite-induced allergic rhinitis alk.net ↗
The expanded approval, which covers patients who are aged 12-17, is based upon data from clinical trials conducted in Japan and North America as part of the global ACARIZAX ® clinical development programme. |
| 2017-03-24 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, submits paediatric registration application for the house dust mite SLIT-tablet in Japan alk.net ↗
The new application is based on results from a safety and efficacy trial involving approximately 400 patients aged 5-17 with house dust mite-induced allergic rhinitis. |
| 2017-03-01 | ALK-Abelló A/S | Regulatory ALK announces FDA approval for its house dust mite sublingual allergy immunotherapy tablet (ACARIZAX® in Europe) alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet. |
| 2016-06-12 | ALK-Abelló A/S | Results Global data highlights worldwide challenge of house dust mite allergy alk.net ↗
At the congress, experts from three continents explained the impact of HDM respiratory allergy and presented clinical data with the SQ ® HDM sublingual allergy immunotherapy (SLIT) tablet recently launched in Europe and Japan, showing consistent benefits in all three populations. |
| 2016-04-27 | ALK-Abelló A/S | Results Journal of the American Medical Association publishes Phase III data from allergic asthma trial with ALK's house dust mite SLIT-tablet, ACARIZAX® alk.net ↗
The results appear in the latest edition of JAMA. |
| 2016-04-13 | ALK-Abelló A/S | Regulatory License application for investigational house dust mite SLIT-tablet accepted for review by FDA alk.net ↗
Today, ALK's ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) partner for North America, MSD (known as Merck (NYSE: MRK) in the United States and Canada), announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet for review. |
| 2016-02-10 | ALK-Abelló A/S | Regulatory ALK's partner, MSD, submits US license application for investigational house dust mite SLIT-tablet alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) announced today that its partner for North America, MSD (known as Merck (NYSE: MRK) in the United States and Canada) has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet). |
| 2016-01-27 | ALK-Abelló A/S | Regulatory Marketing authorisation for ACARIZAX® issued in France alk.net ↗ |
All press releases naming this drug 24 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ACARIZAX | “The patients have received SLIT-HDM (ACARIZAX, ALk Abello, Denmark) with 12 SQ-HDMs of a standardized allergen extract of the house dust mites Dermatophagoides pteronyssinus...” NCT06509243 ↗ |
| Modality | Other / unclassified | “sublingual allergen immunotherapy (Acarizax)” NCT06509243 ↗ |
| Route | Other | “placed under the tongue” NCT06509243 ↗ |