Drugs / SCH 697243
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01385371 | Jun 2011 → Aug 2012 | allergic rhinitis, conjunctivitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT00550550 | Nov 2007 → Sep 2009 | allergic rhinitis, conjunctivitis | ALK-Abelló A/S | Completed | Met primary |
| Phase 3 | NCT00562159 | Nov 2007 → Sep 2009 | allergic disease, conjunctivitis, rhinitis | ALK-Abelló A/S | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2017-08-21 | ALK-Abelló A/S | Regulatory ALK to accelerate launches of ODACTRA™ in the USA / ACARIZAX® in Canada alk.net ↗
ALK today announced that the US Food and Drug Administration (FDA) has completed the transfer to ALK of the Biologics Licences for its tablet portfolio, including GRASTEK ® and RAGWITEK ® and the house dust mite SLIT-tablet ODACTRA™ (marketed as ACARIZAX ® in Europe). |
| 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 ↗
ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF) today released further analysis of data from its landmark five-year GRAZAX ® Asthma Prevention (GAP) clinical trial in children. |
| 2016-01-14 | ALK-Abelló A/S | Results ALK announces top-line results from the five-year landmark GRAZAX® Asthma Prevention (GAP) trial in children alk.net ↗
The trial demonstrated that GRAZAX ® treatment significantly reduced the proportion of children experiencing asthma symptoms or using asthma medication. |
| 2014-04-14 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s GRASTEK® (Timothy Grass Pollen Allergen Extract) Sublingual Tablet as Immunotherapy to Treat Grass Pollen-Induced Allergic Rhinitis with or without Conjunctivitis in Children and Adults merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved GRASTEK ® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use [2800 Bioequivalent Allergy Units (BAU)]. |
| 2014-04-14 | ALK-Abelló A/S | Regulatory ALK announces FDA approval for Merck's grass sublingual allergy immunotherapy tablet GRASTEK® (GRAZAX®) alk.net ↗ |
| 2014-02-03 | Merck Sharp & Dohme LLC | Regulatory Merck Announces Canadian Approval of GRASTEK® (Standardized Allergenic Extract, Timothy Grass (Phleum pratense) Sublingual Tablet) merck.com ↗
Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the regulatory approval and launch of GRASTEK ® (Timothy grass pollen allergen extract) sublingual tablets in Canada. |
| 2013-12-12 | ALK-Abelló A/S | Regulatory FDA Advisory Committee meeting unanimously recommends approval of GRASTEK (GRAZAX®) alk.net ↗ |
All press releases naming this drug 7 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SCH 697243 | “A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum Pratense) Sublingual Tablet (SCH 697243)...” NCT01385371 ↗ |
| Modality | Other / unclassified | “grass allergy immunotherapy tablet (AIT) treatment” PMID 21211643 ↗ Jan 2011 |
| Route | Other | “Grass sublingual tablet, once daily” NCT00550550 ↗ |