Drugs / Viaskin Peanut
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT01955109 | Sep 2013 → Sep 2016 | food allergy | DBV Technologies | Completed | No outcome recorded |
| Phase 2 | NCT01675882 | Aug 2012 → Jul 2014 | food allergy | DBV Technologies | Completed | Met primary |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT03211247 | Jul 2017 → Aug 2019 | food allergy | DBV Technologies | Completed | Met primary |
| Phase 3 | NCT03013517 | Jan 2017 → Nov 2019 | food allergy | DBV Technologies | Unknown | No outcome recorded |
| Phase 3 | NCT02916446 | Oct 2016 → Sep 2017 | food allergy | DBV Technologies | Completed | No outcome recorded |
| Phase 3 | NCT02636699 | Dec 2015 → Aug 2017 | food allergy | DBV Technologies | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04371627 | — | food allergy | DBV Technologies | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | DBV Technologies | Results DBV Technologies to Present New Positive Data from VITESSE Study and Preview Recently Initiated THRIVE Study at the EAACI Congress 2026 dbv-technologies.com ↗
In the Phase 3 VITESSE study, VIASKIN ® Peanut Patch demonstrated statistically significant efficacy vs. placebo in the subgroups of children with peanut allergy who also had another common atopic condition, including asthma, concomitant food allergy, or atopic dermatitis. |
| 2026-02-28 | DBV Technologies | Results DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting dbv-technologies.com ↗
Approximately 83% of children treated with the VIASKIN ® Peanut Patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group |
| 2025-12-16 | DBV Technologies | Results DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years dbv-technologies.com ↗ |
| 2025-03-24 | DBV Technologies | Regulatory DBV Technologies Secures Agreement with FDA on Safety Exposure Data Required for BLA for Viaskin® Peanut Patch in 4–7-year-olds, Accelerating the Timeline for a BLA Filing Submission to 1H 2026, & Reports 2024 Unaudited Financial Results… dbv-technologies.com ↗
As a result, the COMFORT Children supplemental safety study will no longer be required, which accelerates the timeline for a BLA submission of Viaskin ® peanut patch in 4 – 7-year-olds with a peanut allergy. |
| 2025-02-25 | DBV Technologies | Results DBV Technologies to Participate in Upcoming AAAAI/WAO Joint Congress dbv-technologies.com ↗
Among PEOPLE participants, the percentage of treatment responders (per PEPITES criteria) increased from 39.1% at PEPITES completion to 52.9% at M36 to 73.3% at M60 (versus 88% at M60 among PEOPLE participants who completed the double-blind, placebo-controlled food challenge [DBPCFC] at M60). |
| 2025-01-08 | DBV Technologies | Results DBV Technologies Announces Positive 3-Year Results from EPITOPE Phase 3 Open-Label Extension Study dbv-technologies.com ↗
The data provide support that continued treatment with VIASKIN Peanut showed further improvement through 36 months of treatment across all efficacy parameters. |
| 2024-12-11 | DBV Technologies | Regulatory DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old dbv-technologies.com ↗
The FDA has formalized guidance on an Accelerated Approval for the Viaskin Peanut patch in toddlers 1 – 3-years-old. |
| 2024-10-22 | DBV Technologies | Regulatory DBV Announces Positive Regulatory Updates for the Viaskin® Peanut Patch in the United States and Europe dbv-technologies.com ↗
DBV intends to formalize the Accelerated Approval guidance provided by the FDA via submission of a meeting request. |
| 2024-07-30 | DBV Technologies | Regulatory DBV Technologies Provides Updates on the Viaskin Peanut Program in Children and Toddlers and Reports Second Quarter and Half-Year 2024 Financial Results dbv-technologies.com ↗
DBV submitted a labeling proposal, informed by the EPITOPE efficacy data, to the Food and Drug Administration (FDA) to address the FDA’s protocol queries regarding patch wear-time in COMFORT Toddlers |
| 2023-11-09 | DBV Technologies | Results DBV Technologies Announces 2-Year Results from Ongoing Phase 3 Open-Label Extension to the EPITOPE Trial (EPOPEX) of Viaskin™ Peanut in Toddlers dbv-technologies.com ↗
Viaskin Peanut showed improvement between months 12 and 24 of treatment across all efficacy parameters. |
| 2023-05-10 | DBV Technologies | Results DBV Technologies Announces New England Journal of Medicine Publication of Phase 3 EPITOPE Trial Data Evaluating Viaskin™ Peanut in Toddlers dbv-technologies.com ↗ |
| 2023-04-19 | DBV Technologies | Regulatory DBV Technologies Outlines Regulatory Path for Viaskin Peanut in Children 1 – 3 Years After Receiving Pre-BLA Responses from FDA dbv-technologies.com ↗
In the written responses received, the Agency confirmed that the Company’s Phase 3 EPITOPE study met the pre-specified criteria for success for the primary endpoint. |
All press releases naming this drug 13 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Viaskin Peanut | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02916446 ↗ |
| Known as | VP250 | “This study assessed long-term safety of EPIT with VIASKIN peanut patch 250 μg (VP250) via an open-label extension of the REAL Life Use and Safety of EPIT (REALISE) trial.” PMID 40023371 ↗ Feb 20251“OBJECTIVE: To evaluate whether concomitant atopic comorbidities affect the safety and efficacy of VIASKIN peanut patch (patch containing 250 µg peanut protein [VP250]).” PMID 40204253 ↗ Apr 2025 |
| Modality | Protein / enzyme biologic | “250 µg peanut protein” NCT02636699 ↗ |
| Route | Other | “Subjects epicutaneously administered” NCT01675882 ↗ |