sweet vernal, orchard, perennial rye, timothy, and kentucky blue grass mixed pollens allergen extract
Trade name: Oralair
Allergenapproved
Approved
Apr 1, 2014
Allergen immunotherapy, also known as desensitization or hypo-sensitization, is a medical treatment for environmental allergies and asthma. Immunotherapy involves exposing people to increasing amounts of allergens in an attempt to change the immune system's response. — Wikipedia
Clinical trial activity
5 trials · 8 clinical orgs · 1 marketing orgs
Phase 1
1
Phase 2
2
Phase 3
2
Phase 4
1
Earliest trial started Nov 30, 2013 (NCT01992835)
Timeline
2010s
- Apr 2, 2013
Stallergenes — First NDA Organization
- Apr 2, 2013
Stallergenes — NDA Organization
- Apr 1, 2014
Earliest FDA Approval
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
2020s
- Jan 1, 2021
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Grass allergenImmunity, desensitized
Grass allergen immunity, desensitized
Approval history
- approvedApr 1, 2014
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaAllergen immunotherapy ↗
Also known as
- oralair
- oralair
- oralair
- sweet vernal, orchard, perennial rye, timothy and kentucky blue grass mixed pollens allergen extract
- sweet vernal, orchard, perennial rye, timothy, and kentucky blue grass mixed pollens allergen extract
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05119751 | Phase 4 | Oct 25, 2021 | ALK-Abello, S.A., Clinique Spécialisée en Allergies de la Capitale |
| NCT04891237 | Phase 3 | Jun 14, 2021 | Inmunotek S.L. |
| NCT04898283 | Phase 3 | May 31, 2021 | Inmunotek S.L., University of Burgos |
| NCT03931993 | Phase 1 | Jan 16, 2017 | Allergy Therapeutics, Metronomia Clinical Research GMBH, Synteract, Inc. |
| NCT01992835 | N/A | Nov 30, 2013 | University of Strasbourg |
Showing 5 of 5 trials
Page 1 / 1
Organizations
Research & Development (8)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Inmunotek S.L. | For profit | 2 | 2 | 1 | 2021 |
| ALK-Abello, S.A. | For profit | 1 | 0 | 1 | 2021 |
| Allergy Therapeutics | For profit | 1 | 1 | 1 | 2017 |
| Clinique Spécialisée en Allergies de la Capitale | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Metronomia Clinical Research GMBH | For profit | 1 | 0 | 1 | 2017 |
| Synteract, Inc. | For profit | 1 | 0 | 1 | 2017 |
| University of Burgos | Academic/Hospital | 1 | 0 | 1 | 2021 |
| University of Strasbourg | Academic/Hospital | 1 | 1 | 1 | 2013 |
8 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Stallergenes | For profit | NDA | Apr 2, 2013 |