Drugs / BERDAZIMER SODIUM
BERDAZIMER SODIUM
also known as
SB204 · NVN1000 · SB206 · berdazimer · Berdazimere sodique · Berdazimero de sodio · SB206 12% berdazimer sodium · SB208 · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZELSUVMI | — | 2024-01-05 | fda.gov ↗ |
Trials 18
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02801903 | Jun → Aug 2016 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02581072 | Oct → Dec 2015 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02250430 | Sep 2014 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02164084 | Jun 2014 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01844739 | Apr → Jun 2013 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01694810 | Sep → Nov 2012 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01556698 | Jul → Dec 2011 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 25 trials · 1 met primary | ||||||
| Phase 2 | NCT03436615 | Jan → Nov 2018 | molluscum contagiosum | Novan, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02860052 | Jul 2016 → Jan 2017 | tinea pedis | Novan, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02462187 | Jun 2015 → Oct 2016 | anogenital human papillomavirus infection | Novan, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02242760 | Nov 2014 → Jun 2015 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01844752 | Apr → Nov 2013 | acne | Novan, Inc. | Completed | Met primary |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT04535531 | Sep 2020 → Apr 2021 | molluscum contagiosum | Novan, Inc. | Completed | Met primary |
| Phase 3 | NCT03927703 | Jun → Nov 2019 | molluscum contagiosum | Novan, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03927716 | Jun → Oct 2019 | molluscum contagiosum | Novan, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02798120 | May 2016 → Apr 2017 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02672332 | Feb → Dec 2016 | acne | Novan, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02667444 | Feb → Dec 2016 | acne | Novan, Inc. | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 1 | NCT01755247 Comparator | Nov 2012 | acne | Novan, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2023-01-06 | Ligand Pharmaceuticals | Regulatory Ligand’s Partner Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum ligand.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BERDAZIMER SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298064 ↗ |
| Known as | berdazimer | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04535531 ↗ |
| Known as | Berdazimere sodique | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298064 ↗ |
| Known as | Berdazimero de sodio | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298064 ↗ |
| Known as | NVN1000 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01844752 ↗ |
| Known as | SB204 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02250430 ↗ |
| Known as | SB206 | “SB206 10.3% berdazimer” NCT04535531 ↗ |
| Known as | SB206 12% berdazimer sodium | “SB206 12% berdazimer sodium” NCT04535531 ↗ |
| Known as | SB208 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02860052 ↗ |
| Known as | Zelsuvmi | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298064 ↗ |
| Modality | Small molecule | — CHEMBL4298064 ↗ |
| Route | Topical | “NVN1000 Gel topically applied one daily at bedtime for 8 weeks” NCT01556698 ↗ |