Drugs / SOFPIRONIUM
SOFPIRONIUM
also known as
BBI-4000 · Sofpironium Bromide · Bbi-4000 ion · Bromure de sofpironium · Bromuro de sofpironio · Sofdra · Sofpironium cation
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | SOFDRA | — | 2024-06-18 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02058264 | Feb → Aug 2014 | — | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT03785587 | Dec 2018 → Sep 2019 | isolated hyperchlorhidrosis | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03024255 | Dec 2016 → Sep 2017 | isolated hyperchlorhidrosis | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02682238 | Mar → Jul 2016 | hyperhidrosis palmaris ET plantaris | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02336503 | Mar → Nov 2015 | isolated hyperchlorhidrosis | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT03948646 | Dec 2020 → Aug 2021 | isolated hyperchlorhidrosis | Botanix Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03836287 | Oct 2020 → Jun 2021 | — | Botanix Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT03627468 | Sep 2018 → Jan 2020 | isolated hyperchlorhidrosis | Botanix Pharmaceuticals | Completed | No outcome recorded |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SOFPIRONIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Known as | BBI-4000 | “Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.” NCT03948646 ↗5“Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.” NCT03836287 ↗ |
| Known as | Bbi-4000 ion | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Known as | Bromure de sofpironium | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Known as | Bromuro de sofpironio | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Known as | Sofdra | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Known as | Sofpironium Bromide | “Topically Applied BBI-4000 (Sofpironium Bromide) 15% Gel” NCT02682238 ↗5“Topically Applied BBI-4000 (Sofpironium Bromide) Gel” NCT03024255 ↗ |
| Known as | Sofpironium cation | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707224 ↗ |
| Modality | Small molecule | “Sofpironium bromide (BBI-4000) is a novel soft-drug” NCT03785587 ↗ |
| Route | Topical | “topically applied” NCT02058264 ↗ |