Drugs / Grazax
Grazax
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT04502966 | Nov 2020 → Feb 2025 | seasonal allergic rhinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01335139 | Mar 2011 → Feb 2015 | seasonal allergic rhinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT00773240 | Apr → Oct 2008 | seasonal allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT00421655 | Dec 2006 → Aug 2007 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT00227279 | Oct 2004 → Sep 2009 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02437786 | Sep 2009 → Dec 2014 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 4 | NCT01433510 | Nov 2007 → Oct 2010 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT02005627 Comparator | Sep 2013 → Mar 2017 | allergic rhinitis | Imperial College London | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06061848 Comparator | Feb 2023 → Dec 2030 expected | seasonal allergic rhinitis | Lars Olaf Cardell | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT01061203 Comparator | Jan 2010 → Sep 2015 | allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 3 | NCT01740284 Comparator | Sep 2008 → Jan 2009 | allergic disease | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT01854736 Comparator | Apr 2013 → Dec 2015 | seasonal allergic rhinitis | ALK-Abelló A/S | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT01889875 Comparator | Nov 2010 → Aug 2012 | seasonal allergic rhinitis | Bispebjerg Hospital | Completed | No outcome recorded |
Press releases naming this drug 25 releases
| Date | Issuer | Release |
|---|---|---|
| 2017-07-07 | ALK-Abelló A/S | Five-year GRAZAX® Asthma Prevention (GAP) Trial Reveals Benefits of Early Treatment Intervention in Children alk.net ↗ |
| 2016-06-13 | ALK-Abelló A/S | New data from GAP landmark trial confirms GRAZAX® prevents asthma symptoms in children alk.net ↗ |
| 2016-01-14 | ALK-Abelló A/S | ALK announces top-line results from the five-year landmark GRAZAX® Asthma Prevention (GAP) trial in children alk.net ↗ |
| 2014-04-14 | ALK-Abelló A/S | ALK announces FDA approval for Merck's grass sublingual allergy immunotherapy tablet GRASTEK® (GRAZAX®) alk.net ↗ |
| 2014-02-03 | ALK-Abelló A/S | ALK's partner for North America, Merck, announces launch of GRASTEK® (GRAZAX®) in Canada alk.net ↗ |
| 2013-12-12 | ALK-Abelló A/S | FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX®) alk.net ↗ |
| 2013-02-01 | ALK-Abelló A/S | ALK's partner, Merck, submits a BLA to the FDA for a marketing authorisation for grass AIT (GRAZAX® in Europe) alk.net ↗ |
| 2012-09-10 | ALK-Abelló A/S | ALK and MSD enter co-promotion agreement for GRAZAX® in France alk.net ↗ |
| 2012-03-02 | ALK-Abelló A/S | ALK: GRAZAX® long-term trial highlighted as editor's choice in leading scientific journal alk.net ↗ |
| 2011-04-18 | ALK-Abelló A/S | GRAZAX® granted reimbursement in Denmark alk.net ↗ |
| 2010-02-08 | ALK-Abelló A/S | Disease-modifying effect of GRAZAX® verified alk.net ↗ |
| 2009-11-02 | ALK-Abelló A/S | GRAZAX® trial in the US meets primary endpoint alk.net ↗ |
| 2009-09-26 | ALK-Abelló A/S | GRAZAX® approved as a disease modifying allergy treatment alk.net ↗ |
| 2009-06-08 | ALK-Abelló A/S | Improved quality of life and sustained symptom control of GRAZAX® after completion of treatment (EAACI 2009) alk.net ↗ |
| 2008-11-21 | ALK-Abelló A/S | ALK achieves general reimbursement for GRAZAX® in Spain alk.net ↗ |
| 2008-11-20 | ALK-Abelló A/S | GRAZAX® approved in Europe for treatment of children alk.net ↗ |
| 2008-10-22 | ALK-Abelló A/S | Persistent vaccination effect of GRAZAX® after completion of treatment alk.net ↗ |
| 2008-09-25 | ALK-Abelló A/S | Allergy vaccine tablet GRAZAX® honoured as Product of the Year alk.net ↗ |
| 2008-03-01 | ALK-Abelló A/S | ALK-Abelló announces positive third year results from clinical study with GRAZAX® alk.net ↗ |
| 2007-11-22 | ALK-Abelló A/S | Favourable results from GRAZAX® study in children alk.net ↗ |
| 2007-03-05 | ALK-Abelló A/S | ALK-Abelló launches GRAZAX® in Sweden as a therapy eligible for full reimbursement alk.net ↗ |
| 2006-12-21 | ALK-Abelló A/S | ALK-Abelló, positive second year results from clinical study with Grazax alk.net ↗ |
| 2006-12-11 | ALK-Abelló A/S | ALK-Abelló, ALK-Abelló is initiating a Phase III study with GRAZAX® in the USA alk.net ↗ |
| 2006-09-25 | ALK-Abelló A/S | ALK-Abelló, Grazax® approved in Europe alk.net ↗ |
| 2006-03-14 | ALK-Abelló A/S | ALK-Abelló, Grazax approved in Sweden alk.net ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Grazax | “the efficacy of a rapidly dissolving grass allergen tablet (GRAZAX, ALK-Abelló, Hørsholm, Denmark) compared with placebo” PMID 16890769 ↗ Aug 200612“Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy.” PMID 17620076 ↗ Aug 2007 |
| Known as | Phleum Pratense grass pollen allergen extract | “1 tablet (oral lyophilisate ) on Day 14 and Day 28 of Grazax (Phleum Pratense grass pollen allergen extract) 75.000 SQ-T” NCT01740284 ↗ |
| Known as | Sublingual immunotherapy (SLIT) | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01335139 ↗ |
| Modality | Other / unclassified | “a rapidly dissolving grass allergen tablet” PMID 16890769 ↗ Aug 2006 |
| Route | Oral | “oral lyophilisate” PMID 23725348 ↗ Jun 2013 |