Drugs / Peanut (Arachis hypogaea) allergen powder-dnfp
Peanut (Arachis hypogaea) allergen powder-dnfp
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT02635776 | Dec 2015 → Dec 2017 | food allergy | Aimmune Therapeutics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2024-07-30 | Stallergenes Greer | Regulatory FDA approves U.S. pediatric indication extension for Palforzia® oral immunotherapy for the treatment of peanut allergy stallergenesgreer.com ↗
Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, today announced that the U.S Food and Drug Administration (FDA) has approved Palforzia ® [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-07-30 | Stallergenes Greer | FDA approves U.S. pediatric indication extension for Palforzia® oral immunotherapy for the treatment of peanut allergy stallergenesgreer.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Peanut (Arachis hypogaea) allergen powder-dnfp | “Efficacy, determined using double-blind, placebo-controlled food challenges (DBPCFCs), of oral immunotherapy with peanut (Arachis hypogaea) allergen powder-dnfp (PTAH;...” PMID 36915184 ↗ Mar 2023 |
| Known as | AR101 | “The benefit of daily administration of Peanut (Arachis hypogaea) Allergen Powder-dnfp (PTAH)-formerly AR101-has been established in clinical trials” PMID 34320250 ↗ Sep 2021 |
| Known as | Palforzia | “Efficacy, determined using double-blind, placebo-controlled food challenges (DBPCFCs), of oral immunotherapy with peanut (Arachis hypogaea) allergen powder-dnfp (PTAH;...” PMID 36915184 ↗ Mar 2023 |
| Known as | PTAH | “Efficacy, determined using double-blind, placebo-controlled food challenges (DBPCFCs), of oral immunotherapy with peanut (Arachis hypogaea) allergen powder-dnfp (PTAH;...” PMID 36915184 ↗ Mar 2023 |
| Modality | Protein / enzyme biologic | “Study product provided as peanut protein in pull-apart capsules or sachets” NCT02635776 ↗ |
| Route | Oral | “oral immunotherapy” NCT02635776 ↗ |