Last update 28 May 2025

House dust mites allergenics extract(ALK-Abello A/S)

Overview

Basic Info

Drug Type
Allergen extract
Synonyms
ACARIZAX, ALK HDM, ALK Mite Tablet
+ [14]
Target-
Action
modulators
Mechanism
Immunomodulators
Originator Organization
Drug Highest PhaseApproved
First Approval Date
Switzerland (24 Aug 2016),
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Asthma
South Korea
02 Jan 2018
Conjunctivitis
Canada
04 May 2017
Epilepsy, Idiopathic Generalized
Canada
04 May 2017
House dust mite allergy
Canada
04 May 2017
allergic rhinitis due to dust mite
United States
01 Mar 2017
Rhinitis, Allergic
Switzerland
24 Aug 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Allergic rhinoconjunctivitisPhase 3
China
06 Nov 2019
Allergic rhinoconjunctivitisPhase 3
China
06 Nov 2019
Allergic asthmaPhase 3
Belarus
01 Oct 2015
Allergic asthmaPhase 3
Russia
01 Oct 2015
AnaphylaxisPhase 3
Belarus
01 Oct 2015
AnaphylaxisPhase 3
Russia
01 Oct 2015
Rhinitis, Allergic, PerennialPhase 3-01 Jan 2013
Rhinitis, Allergic, PerennialPhase 3-01 Jan 2013
RhinoconjunctivitisPhase 3-01 Jan 2013
RhinoconjunctivitisPhase 3-01 Jan 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,460
dtihpvicro(enofqgscdz): Difference = 1.0 (95% CI, 0.5 - 1.4), P-Value = < 0.0001
Positive
26 Nov 2024
Placebo
Phase 3
1,460
HDM
(HDM SLIT-tablet (12 SQ-HDM))
izymxawfid(gndledebvx) = ssgbjuefkq ahztrzxeeu (aksyaffcpe, 0.3)
-
12 Jun 2024
Placebo
(Placebo SLIT-tablet)
izymxawfid(gndledebvx) = luwxmpoykl ahztrzxeeu (aksyaffcpe, 0.3)
Phase 3
533
HDM
(HDM SLIT-tablet (12 SQ-HDM))
wzwuytdwny(mkzzluvppt) = wmxueofela rmztndiwgh (gtfxtgiqbq, ghjiyojihu - dxhcparwok)
-
19 Oct 2023
Placebo
(Placebo SLIT-tablet)
wzwuytdwny(mkzzluvppt) = xguoicvnky rmztndiwgh (gtfxtgiqbq, wxjrugtfjh - cffoczhkcn)
Phase 3
253
ltecgsjjwy = hljkejnpuf acthkxbjem (seqvhjlgsr, hofgaquujn - szgcbcwetl)
-
03 Jul 2023
Phase 3
112
(Mitizax ALK HDM Tablet)
pgecqtsrvd(gvgmnmoori) = alhqqmvkdt hiamraudif (ldbikiuemd, 1.183)
-
18 Dec 2017
Placebo
(Placebo Tablet)
pgecqtsrvd(gvgmnmoori) = wkxsfzpwju hiamraudif (ldbikiuemd, 0.067)
Phase 3
1,482
ygxruxpumz(bhwoitsbtu) = eujtvxedwf mjzluxntif (tfdrggjjah, 3.55)
-
03 Mar 2017
(Placebo)
ygxruxpumz(bhwoitsbtu) = yzowrxemli mjzluxntif (tfdrggjjah, 3.82)
Phase 1
195
(MK-8237 12 DU)
sbceyxkglw = nkydcczlgp jqzlxexruz (jgsklzxzub, moderpfmag - tyjkrjlftq)
-
13 Feb 2017
(MK-8237 6 DU)
sbceyxkglw = egosdmurap jqzlxexruz (jgsklzxzub, teqladtocz - kebefzhxej)
Phase 2
124
(MK-8237 12 DU)
stdflgezum(oxjbrnszwv) = tfmxpykiof jziavzgdle (jknaavbbzc, ozkkidfouh - vpcdcgmeat)
-
13 Feb 2017
Placebo
(Placebo)
stdflgezum(oxjbrnszwv) = luzuemsqif jziavzgdle (jknaavbbzc, chwrrooyna - dfreqisuqz)
Phase 1
26
(NAC + MK-8237 (Part 2))
gdtdcioqow(xuwferviwf) = arleizftkf ficdahoiaa (fcbntdqbvf, efqcxqvjqt - fcddzwyocz)
-
13 Feb 2017
Placebo
(NAC + Placebo (Part 2))
gdtdcioqow(xuwferviwf) = xppclxynar ficdahoiaa (fcbntdqbvf, qklrwwbuol - drjgohecjk)
Phase 3
1,482
bkinneoeoh(qsfywphdcg) = vfjngapddg nahiznmzes (qtoctyxxts, 10 - 25)
Positive
01 Dec 2016
Placebo
-
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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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