timothy grass pollen allergen extract
Trade name: Grastek
Allergenapproved
Approved
Mar 13, 1924
Timothy is an abundant perennial grass native to most of Europe except for the Mediterranean region. It is also known as timothy-grass, meadow cat's-tail or common cat's tail. It is a member of the genus Phleum, consisting of about 15 species of annual and perennial grasses. — Wikipedia
Clinical trial activity
63 trials · 48 clinical orgs · 4 marketing orgs
Phase 1
8
Phase 2
40
Phase 3
25
Phase 4
9
Earliest trial started May 1, 1999 (NCT00001864)
Timeline
1920s
- Mar 13, 1924
Jubilant Innovation Ltd. — Earliest FDA Approval
- Mar 13, 1924
Jubilant Innovation Ltd. — NDA Secondary Org
- Mar 13, 1924
Jubilant Innovation Ltd. — NDA Organization
1930s
- Jun 14, 1930
Allermed Laboratories — NDA Secondary Org
- Jun 14, 1930
Greer Laboratories — NDA Secondary Org
- Jun 14, 1930
ALK-Abello, S.A. — NDA Secondary Org
1990s
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Allergy and Immunology · Phase 3
- Amblyopia · Phase 3
- Anisometropia · Phase 3
- Asthma · Phase 3
- Conjunctivitis · Phase 4
- Conjunctivitis, Allergic · Phase 3
- Healthy Volunteers · Phase 2
- Hypersensitivity · Phase 4
- Hypersensitivity, Immediate · Phase 3
- Immunotherapy · Phase 4
- Rhinitis · Phase 3
- Rhinitis, Allergic · Phase 4
- Rhinitis, Allergic, Perennial · Phase 3
- Rhinitis, Allergic, Seasonal · Phase 4
- Strabismus · Phase 3
Mechanism of action
- Grass allergenImmunity, desensitized
Grass allergen immunity, desensitized
Approval history
- approvedMar 13, 1924
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaTimothy (grass) ↗
- NCATSS7PW24BX20 ↗
- WikipediaTimothy-grass ↗
Also known as
- depigold grasses
- grass allergen
- grass allergen extract
- grass mata
- grass pollen
- grass pollen allergen
- grass pollen allergen extract
- grass pollen allergens
- grass-spire
- grastek
- grastek
- pollens - grasses, timothy phleum pratense
- purethal grasses
- sublivac grasses
- timothy grass allergen
- timothy grass pollen allergen extract
- toleromune grass
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04603456 | Phase 4 | Sep 1, 2018 | Zagazig University |
| NCT03558997 | Phase 2 | Jun 14, 2018 | Regeneron, Sanofi |
| NCT03375775 | N/A | May 1, 2017 | Karolinska Institute |
| NCT02949050 | N/A | Aug 1, 2016 | United Allergy Services |
| NCT02795273 | Phase 2/Phase 3 (Phase 3) | May 1, 2016 | Circassia Limited, University of Cincinnati |
| NCT02643641 | Phase 2 | Jan 1, 2016 | Biomay AG, Medical University of Vienna |
| NCT02582073 | Phase 2 | Nov 7, 2015 | Allergy Therapeutics |
| NCT02443805 | Phase 3 | Sep 1, 2015 | Stallergenes, University of Montpellier, University of South Florida |
| NCT02557633 | Phase 1 | Aug 1, 2015 | Allergy Therapeutics, Inflamax, Metronomia Clinical Research GMBH |
| NCT02679105 | Phase 2/Phase 3 (Phase 3) | May 1, 2015 | Karolinska Institute, Lund University, Sodra Alvsborgs Hospital |
| NCT02394600 | Phase 4 | Apr 1, 2015 | Merck, Queen's University, Belfast |
| NCT02161107 | Phase 2 | Apr 1, 2014 | Adiga Life Sciences, Inc., Circassia Limited |
| NCT02014623 | Phase 4 | Feb 1, 2014 | Monash University |
| NCT02297490 | Phase 2 | Jan 1, 2014 | Allergopharma GmbH & Co. KG, Inflamax |
| NCT01982474 | Phase 1 | Oct 1, 2013 | Ohio State University |
| NCT01734265 | Phase 2 | Nov 1, 2012 | H. Virgen Macarena, Leti Pharma GmbH |
| NCT01591343 | Phase 2 | Jun 1, 2012 | Harrison Clinical Research, Leti Pharma GmbH |
| NCT01538979 | Phase 2 | Mar 1, 2012 | Biomay AG |
| NCT01785394 | Phase 4 | Feb 1, 2012 | Association Asthma, Bulgaria |
| NCT01445002 | Phase 2 | Oct 1, 2011 | Biomay AG |
Showing 20 of 63 trials
Page 1 / 4
Organizations
Research & Development (48)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Allergopharma GmbH & Co. KG | For profit | 8 | 7 | 3 | 2001 |
| Allergy Therapeutics | For profit | 8 | 8 | 3 | 2005 |
| Stallergenes | For profit | 7 | 7 | 2 | 2004 |
| ALK-Abello, S.A. | For profit | 6 | 6 | 2 | 2004 |
| Biomay AG | For profit | 4 | 4 | 1 | 2011 |
| Circassia Limited | For profit | 4 | 4 | 2 | 2010 |
| Adiga Life Sciences, Inc. | For profit | 3 | 0 | 1 | 2010 |
| Karolinska Institute | Academic/Hospital | 3 | 3 | 2 | 2010 |
| Leti Pharma GmbH | For profit | 3 | 3 | 1 | 2007 |
| Medical University of Lodz | Academic/Hospital | 3 | 2 | 1 | 2003 |
| HAL Allergy | For profit | 2 | 2 | 2 | 2006 |
| Immune Tolerance Network | Academic/Hospital | 2 | 0 | 1 | 2006 |
| Inflamax | For profit | 2 | 0 | 2 | 2014 |
| Lund University | Academic/Hospital | 2 | 0 | 1 | 2010 |
| Medical University of Vienna | Academic/Hospital | 2 | 0 | 2 | 2007 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 2 | 2 | 1 | 2006 |
| Queen's University, Belfast | Academic/Hospital | 2 | 1 | 2 | 2011 |
| University of Zurich | Academic/Hospital | 2 | 2 | 1 | 2008 |
| Allergists and Immunologists, Fort Lauderdale | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Artu Biologicals | For profit | 1 | 1 | 1 | 2006 |
48 organizations
Page 1 / 3
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ALK-Abello, S.A. | For profit | NDA2 | Jun 14, 1930 |
| Allermed Laboratories | For profit | NDA2 | Jun 14, 1930 |
| Greer Laboratories | For profit | NDA2 | Jun 14, 1930 |
| Jubilant Innovation Ltd. | For profit | NDA2 | Mar 13, 1924 |
| Jubilant Innovation Ltd. | For profit | NDA | Mar 13, 1924 |