Drugs / ATx201
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03375957 | Jan → Feb 2018 | — | UNION therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03301870 | Oct → Nov 2017 | — | UNION therapeutics | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03009734 | Dec 2016 → Mar 2018 | bacterial infectious disease | UNION therapeutics | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04339985 | Oct 2019 → Oct 2020 | atopic eczema | UNION therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03429595 | Feb → Jun 2018 | impetigo | UNION therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03304470 | Sep 2017 → Mar 2018 | atopic eczema | UNION therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2020-07-01 | UNION therapeutics | Results The Journal of Investigative Dermatology Publish UNION therapeutics’ Phase 2 Clinical Trial Results uniontherapeutics.com ↗
The study found topical application of ATx201 to be safe and to significantly impact biomarkers of relevance to the skin barrier function and inflammatory processes across multiple Th cell pathways associated with atopic dermatitis (AD). |
| 2018-12-19 | UNION therapeutics | Results UNION therapeutics Announces Completion of Phase 2 studies with ATx201 uniontherapeutics.com ↗
UNION therapeutics A/S (“UNION”), a privately held, clinical stage, pharmaceutical company targeting inflammatory and microbiome-related disorders, today announced results from two positive Phase 2 studies with its lead compound ATx201 in atopic dermatitis. |
| 2018-10-29 | UNION therapeutics | Results UNION therapeutics Announces Successful Phase 1 Study Completion with ATx201 uniontherapeutics.com ↗
In comparing the active group to placebo, no signs of sensitization were observed, and no subjects showed any signs of unexpected adverse events. |
| 2017-11-01 | UNION therapeutics | Regulatory FDA Approves IND to Conduct Clinical Studies with ATx201 in USA uniontherapeutics.com ↗
the U.S Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval of AntibioTx’s ATx201 for treatment of microbiome related skin disorders. |
| 2017-06-02 | UNION therapeutics | Results AntibioTx to Present Phase I DECOLAD Results at the 26th EADV uniontherapeutics.com ↗
The study enrolled 36 healthy volunteers and supported an excellent safety profile of ATx201. |
| 2017-04-05 | UNION therapeutics | Results AntibioTx Announces Phase I Study Results for ATx201 uniontherapeutics.com ↗
We are pleased about the top-line data which show no signs of unexpected adverse events. |
| 2016-09-19 | UNION therapeutics | Results AntibioTx Concludes 28-day Repeat Dosing in Göttingen Minipigs with Positive Results uniontherapeutics.com ↗
A 28-day repeat dosing study in Göttingen minipigs concluded that proprietary formulations of ATx201 are well tolerated and leads to very low systemic exposure. |
| 2016-08-07 | UNION therapeutics | Results In vivo Efficacy Studies of ATx201 Compares Favorably with Marketed Products uniontherapeutics.com ↗
Recent in vivo studies in mice documents the antibacterial properties of ATx201 and that they compare favorably to marketed products. |
All press releases naming this drug 13 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ATx201 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03009734 ↗ |
| Route | Topical | “Topical application of ATx201 dermal formulations 2%” NCT03009734 ↗ |