Dermatophagoides pteronyssinus

Overview

Dermatophagoides pteronyssinus extracts are sterile solutions used for intradermal testing or subcutaneous immunotherapy. This combination is approved for as a year-round, once-a-day tablet that's dissolved under the tongue as a treatment for dust mite allergies.

Indication

Dermatophagoides pteronyssinus is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. It is approved for use in patients 12 through 65 years of age.

Associated Conditions

House Dust Mite Allergy

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Potency of HDM Sublingual AIT Tablets in Assuring the Persistency of Asthma Control in HDM Allergic Patients With Severe Asthma, Treated With Tezepelumab	2025/06/10	NCT07013123	Phase 3	Not yet recruiting	University Hospital, Montpellier
The Effect of Allergen Immunotherapy on Anti-viral Immunity in Patients With Allergic Asthma	2019/09/24	NCT04100902	Phase 4	Completed	Bispebjerg Hospital
Distinct Response of CD4+CD25+Foxp3+ and IL-10-secreting Type I T Regulatory Cells to Cluster Specific Immunotherapy in Allergic Rhinitis Children	2011/02/08	NCT01291381	Not Applicable	Completed	Beijing Tongren Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Treatment Set TS346157	Antigen Laboratories, Inc.	49288-0854	SUBCUTANEOUS, INTRADERMAL	1000 [AU] in 1 mL	5/11/2012
Treatment Set TS332291	Antigen Laboratories, Inc.	49288-0762	SUBCUTANEOUS, INTRADERMAL	16 [AU] in 1 mL	12/2/2009
Treatment Set TS336437	Antigen Laboratories, Inc.	49288-0786	SUBCUTANEOUS, INTRADERMAL	400 [AU] in 1 mL	6/17/2010
Treatment Set TS331975	Antigen Laboratories, Inc.	49288-0736	SUBCUTANEOUS, INTRADERMAL	400 [AU] in 1 mL	12/2/2009
Treatment Set TS331632	Antigen Laboratories, Inc.	49288-0708	SUBCUTANEOUS, INTRADERMAL	833.33 [AU] in 1 mL	12/2/2009
Treatment Set TS330821	Antigen Laboratories, Inc.	49288-0765	SUBCUTANEOUS, INTRADERMAL	400 [AU] in 1 mL	12/2/2009
Treatment Set TS333938	Antigen Laboratories, Inc.	49288-0657	SUBCUTANEOUS, INTRADERMAL	1000 [AU] in 1 mL	12/2/2009
Treatment Set TS335657	Antigen Laboratories, Inc.	49288-0780	SUBCUTANEOUS, INTRADERMAL	16 [AU] in 1 mL	4/26/2010
Treatment Set TS330376	Antigen Laboratories, Inc.	49288-0705	SUBCUTANEOUS, INTRADERMAL	166.67 [AU] in 1 mL	12/2/2009
Treatment Set TS345048	Antigen Laboratories, Inc.	49288-0840	INTRADERMAL, SUBCUTANEOUS	2000 [AU] in 1 mL	3/23/2012

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ALUSTAL EUROPEAN DUST MITE EXTRACT european house dust mite 10.0 IR/mL injection suspension vial	132678	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006
ACARIZAX (American house dust mite extract and European house dust mite extract) SUBLINGUAL TABLET	250392	Seqirus Pty Ltd	Medicine	A	8/1/2016
ACTAIR Initiation Treatment 100IR & 300IR sublingual tablets blister pack	233470	Stallergenes Australia Pty Ltd	Medicine	A	4/15/2016
ALUSTAL EUROPEAN DUST MITE EXTRACT european house dust mite injection suspension vial composite pack	132723	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006
ALUSTAL HOUSE DUST MITES EXTRACT INITIAL TREATMENT european house dust mite and american house dust mite injection suspension vial composite pack	132725	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006
ACTAIR Continuation Treatment 300IR sublingual tablets blister pack	233471	Stallergenes Australia Pty Ltd	Medicine	A	4/15/2016
Dermatophagoids Pteronyssinus Scratch Test (30,000AU/mL) & Treatments (10,000AU/mL & 30,000AU/mL)	32421	Stallergenes Australia Pty Ltd	Medicine	A	11/1/1991
ALUSTAL HOUSE DUST MITES EXTRACT MAINTENANCE european house dust mite and american house dust mite 10.0 IR/mL injection suspension vial	132680	Stallergenes Australia Pty Ltd	Medicine	A	10/3/2006

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ALLERGENIC EXTRACT STANDARDIZED MITE DP	hollister-stier, unit pharm, division of miles canada inc.	01959131	Liquid - Subcutaneous	30000 UNIT / ML	12/31/1992
ALLERGENIC EXTRACT STANDARDIZED MITE MIX	hollister-stier, unit pharm, division of miles canada inc.	01959182	Liquid - Subcutaneous	15000 UNIT / ML	12/31/1992
ALLERGENIC EXTRACT STANDARDIZED MITE DP (10,000 AU/ML)	JUBILANT HOLLISTERSTIER LLC	02223937	Solution - Percutaneous , Subcutaneous	10000 UNIT / ML	1/16/1998
ALLERGENIC EXTRACT - STANDARDIZED MITE MIX	greer laboratories inc	02231325	Liquid - Subcutaneous , Intracutaneous	5000 UNIT / ML	8/20/2002
ALLERGENIC EXTRACTS - STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS	greer laboratories inc	02369745	Liquid - Intradermal , Subcutaneous	30000 UNIT / ML	N/A
ALLERGENIC EXTRACT - STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS	greer laboratories inc	02231324	Liquid - Intracutaneous , Subcutaneous	10000 UNIT / ML	3/15/1999
ALLERGENIC EXTRACT, STANDARDIZED MITE MIXED	alk-abello inc	02270919	Liquid - Intradermal , Percutaneous , Subcutaneous	5000 UNIT / ML	2/28/2006
STANDARDIZED MITE, MITE MIX - LIQ	allergologisk lab a/s	02118106	Liquid - Intradermal , Subcutaneous	5000 UNIT / ML	12/31/1994
ALLERGENIC EXTRACT, STANDARDIZED MITE, D.PTERONYSSINUS	alk-abello inc	02217104	Liquid - Intradermal , Percutaneous , Subcutaneous	10000 UNIT / ML	9/15/1997
ALLERGENIC EXTRACT MIXTURE OF STANDARDIZED MITES (5,000 AU/ML)	JUBILANT HOLLISTERSTIER LLC	02223996	Solution - Subcutaneous , Percutaneous	5000 UNIT / ML	1/16/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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