Drugs / Acarizax
Acarizax
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Other | ACARIZAX ® | allergic rhinitis | — | “The New Drug Submission (NDS) for ACARIZAX ® was filed with Health Canada in May 2016.” alk.net ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT07060885 | Sep 2025 → Sep 2026 overdue | allergic rhinitis | ALK-Abelló A/S | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2024-12-12 | ALK-Abelló A/S | Regulatory ACARIZAX® approved in Europe for treatment of young children alk.net ↗ |
| 2023-10-11 | ALK-Abelló A/S | Results Large Phase 3 clinical trial successfully meets primary endpoint, confirming the potential of ALK’s tree tablet in children alk.net ↗
ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of tree-pollen-induced allergic rhinoconjunctivitis. |
| 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 ↗
ALK (ALKB:DC / OMX: ALK B / AKBLF) today announced top-line results from a Phase 3 paediatric clinical trial of its sublingual allergy immunotherapy tablet for the treatment of house dust mite (HDM)-induced allergic rhinitis. |
| 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. |
| 2019-06-07 | ALK-Abelló A/S | Regulatory ALK obtains European approval for its tree SLIT-tablet against allergic rhinitis alk.net ↗
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that it has successfully completed the marketing authorisation procedure for its tree sublingual allergy immunotherapy (SLIT) tablet in 17 European countries. |
| 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 ↗
Approximately 9 out of 10 trial subjects with 'moderately or severely affected sleep' saw an improvement following treatment with ALK’s HDM SLIT-tablet. |
| 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 ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF ) today announced that its partner for Japan, Torii, has gained approval from the Japanese Ministry of Health, Labour and Welfare, to expand the use of ALK’s house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet MITICURE™ to include paediatric allergic rhinitis patients. |
| 2017-08-21 | ALK-Abelló A/S | Regulatory ALK to accelerate launches of ODACTRA™ in the USA / ACARIZAX® in Canada alk.net ↗
The FDA has today transferred the US product licences for the SLIT-tablet portfolio to ALK allowing the company to give full speed on the US activities |
| 2017-07-07 | ALK-Abelló A/S | Results Five-year GRAZAX® Asthma Prevention (GAP) Trial Reveals Benefits of Early Treatment Intervention in Children alk.net ↗
The analysis, which appears online in press in The Journal of Allergy and Clinical Immunology , shows that the benefits of GRAZAX ® in prevention of asthma symptoms were even more pronounced when treatment was initiated at an earlier age. |
| 2017-06-20 | ALK-Abelló A/S | Results ALK symposium reveals early treatment is critical for respiratory allergic disease in children and adolescents alk.net ↗
ALK’s grass SLIT-tablet GRAZAX ® showed the ability to reduce AR symptoms long-term, and to prevent the development of asthma symptoms in children with AR. |
| 2017-05-04 | ALK-Abelló A/S | Regulatory ALK's HDM SLIT-tablet, ACARIZAX®, approved in Canada alk.net ↗
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. |
| 2017-03-24 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, submits paediatric registration application for the house dust mite SLIT-tablet in Japan alk.net ↗ |
| 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 ↗
Copenhagen, 2017-03-01 23:02 CET (GLOBE NEWSWIRE) -- 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. |
| 2016-02-10 | ALK-Abelló A/S | Regulatory ALK's partner, MSD, submits US license application for investigational house dust mite SLIT-tablet alk.net ↗ |
| 2016-01-27 | ALK-Abelló A/S | Regulatory Marketing authorisation for ACARIZAX® issued in France alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that authorities in France, the world's biggest sublingual allergy immunotherapy market, have issued a marketing authorisation for ALK's new house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet), ACARIZAX ® . |
| 2015-11-26 | ALK-Abelló A/S | Regulatory New medicine for house dust mite allergic rhinitis now available in Japan alk.net ↗
ALK ( ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that the sublingual allergy immunotherapy product MITICURE™ now will be available for prescription in Japan for adults and adolescents (12-64 years) who suffer from house dust mite allergic rhinitis. |
| 2015-09-28 | ALK-Abelló A/S | Regulatory ALK's partner, Torii, obtains approval for the house dust mite SLIT-tablet in Japan alk.net ↗
ALK today announced that the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application for the house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet MITICURE™. |
All press releases naming this drug 26 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acarizax | “For daily administration (1 tablet per day) Other Names: Acarizax, Odactra” NCT07060885 ↗ |
| Known as | HDM SLIT-tablet | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07060885 ↗ |
| Known as | Odactra | “For daily administration (1 tablet per day) Other Names: Acarizax, Odactra” NCT07060885 ↗ |