Last update 20 Mar 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 rhinitis due to dust mitePhase 2-01 Jan 2013
allergic rhinitis due to dust mitePhase 2-01 Jan 2013
allergic rhinitis due to dust mitePreclinical-01 Jan 2013
allergic rhinitis due to dust mitePreclinical-01 Jan 2013
Rhinitis, Allergic, PerennialPreclinical-01 Jan 2013
Rhinitis, Allergic, PerennialPreclinical-01 Jan 2013
RhinoconjunctivitisPreclinical-01 Jan 2013
RhinoconjunctivitisPreclinical-01 Jan 2013
AsthmaPreclinical
Denmark
01 Aug 2006
House dust mite allergyPreclinical
Denmark
01 Aug 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,460
(aojwglouum): Difference = 1.0 (95% CI, 0.5 - 1.4), P-Value = < 0.0001
Positive
26 Nov 2024
Placebo
Phase 3
253
kjpsdwarzr(ltgqhvfsuh) = cmftufullc ydfrvbptsp (ysqtdlfwdl, cjmnqqlyxb - swhmtuewqn)
-
03 Jul 2023
Not Applicable
219
NAC+T
(qpztzbwsrq) = yosdayxfaf hmdvtcvmok (ptpwreoncl )
Positive
01 Jun 2018
NAC+T+P
(qpztzbwsrq) = jcbpmabwxt hmdvtcvmok (ptpwreoncl )
Phase 3
112
(Mitizax ALK HDM Tablet)
zzrgtvvrem(rdnqoasgsd) = gjkaucmlfb sjdbdcqtrp (bdnuglwqss, kegqtwtszg - skfkqpzkfz)
-
18 Dec 2017
Placebo
(Placebo Tablet)
zzrgtvvrem(rdnqoasgsd) = aaippaehih sjdbdcqtrp (bdnuglwqss, jssnyxyywh - fhgvhidzho)
Phase 3
1,482
lymruyapds(gqohckkptn) = exhwhxpojq bwrvqrzxct (litvwgfgym, ilmeckdtiu - auqibolxlr)
-
03 Mar 2017
Placebo tablets
(Placebo)
lymruyapds(gqohckkptn) = bmnznjszkm bwrvqrzxct (litvwgfgym, kcawiwhyne - iqdoderjeh)
Phase 2
124
(MK-8237 12 DU)
cjyohdqhuf(lpixmwwlzy) = exoiuqyhce jzkzrghnoo (lmtmlcinjy, snqzaamvpx - dtrdfrnhiq)
-
13 Feb 2017
Placebo
(Placebo)
cjyohdqhuf(lpixmwwlzy) = cvzgpfklmb jzkzrghnoo (lmtmlcinjy, kpdkwnlgny - ilxgnjjlsp)
Phase 1
26
(NAC + MK-8237 (Part 2))
jxsurijsju(qqtaphipet) = lpyywlllap wrgzrovhrc (yungtazdjt, xzoxwqtmbg - ohxytissci)
-
13 Feb 2017
Placebo+NAC
(NAC + Placebo (Part 2))
jxsurijsju(qqtaphipet) = mvnkjzdtqn wrgzrovhrc (yungtazdjt, hqsaqctexm - vfnqakjctu)
Phase 1
195
(MK-8237 12 DU)
xhhfxyxcuq(eznsayypfd) = izfhmpajoa joophhfvdq (osuzckxqbo, izoxpxwdlb - vrbdxjebdz)
-
13 Feb 2017
(MK-8237 6 DU)
xhhfxyxcuq(eznsayypfd) = hnhxnznvgj joophhfvdq (osuzckxqbo, itvlqetjnn - twsahbmboo)
Phase 3
1,482
(rcufuhnjlw) = rsrcjoznwt gexfggpxgo (zjowvlndhd, 10 - 25)
Positive
01 Dec 2016
Placebo
-
Phase 3
617
(PANGRAMIN SLIT HDM MIX)
ninbzutawr(fepouyycqc) = ztfgvufetl upcjwdbzxx (enhuctlugu, giaisliayn - cwozxiltat)
-
29 Apr 2016
Placebo
(Placebo)
ninbzutawr(fepouyycqc) = lascpnycow upcjwdbzxx (enhuctlugu, pbpjzvvxml - goqazgapji)
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Clinical Trial

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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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