Drugs / Secnidazole
Secnidazole
also known as
SYM-1219 · Deprozol · Flagentyl · NSC-759812 · Ornidazole metabolite m4 · PM-185184 · RP 14539 · Sabima · +5 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed trichomoniasis 1 milestone | |||||
| Filed | US (FDA) | Solosec® | trichomoniasis | 2020-11-16 | “the U.S. Food and Drug Administration (FDA) has accepted their supplemental New Drug Application (sNDA) for Solosec® (secnidazole) for the treatment of trichomoniasis in adults.” lupin.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansions (2) | US (FDA) | SOLOSEC | — | 2021-06-30 – 2022-01-26 | fda.gov ↗ |
| Approved | US (FDA) | SOLOSEC | — | 2017-09-15 | fda.gov ↗ |
Trials 11
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT01019083 | Feb 2008 → Dec 2010 | cholera, typhoid fever | International Centre for Diarrhoeal Disease Research, Bangladesh | Completed | No outcome recorded |
| Phase 21 trial · 1 met primary | ||||||
| Phase 2 | NCT02147899 | May → Oct 2014 | bacterial vaginosis | Symbiomix Therapeutics | Completed | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05033743 | Jul 2021 → Oct 2022 | bacterial vaginosis | Indiana University | Completed | No outcome recorded |
| Phase 35 trials · 1 met primary | ||||||
| Phase 3 | NCT03935217 | Apr 2019 → Mar 2020 | trichomoniasis | Lupin Research Inc | Completed | Met primary |
| Phase 3 | NCT02452866 | Jun → Oct 2015 | bacterial vaginosis | Symbiomix Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02418845 | May → Oct 2015 | bacterial vaginosis | Symbiomix Therapeutics | Completed | No outcome recorded |
| Phase 3 | NCT02111629 | May 2012 → Feb 2013 | vaginal discharge | National University of Colombia | Completed | No outcome recorded |
| Phase 3 | NCT01733966 | May 2010 → Mar 2012 | diverticulitis of colon | Quanta Medical | Terminated | No outcome recorded Stop: Enrollment |
| Phase 42 trials | ||||||
| Phase 4 | NCT06261840 | May 2025 → May 2029 expected | Trichomonas vaginitis urogenital infection, bacterial vaginosis | Tulane University | Recruiting | No outcome recorded |
| Phase 4 | NCT03937869 | Nov 2018 → Nov 2020 | bacterial vaginosis | Lupin Research Inc | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT00607074 | Jun 2003 → Apr 2004 | giardiasis | University of Cambridge | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2022-02-17 | Lupin Limited | Regulatory Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) in Adolescents for both the Treatment of Bacterial Vaginosis in Females and Trichomoniasis lupin.com ↗
The supplemental adolescent approval enhances SOLOSEC’s® strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV. |
| 2021-07-01 | Lupin Limited | Regulatory Lupin Announces FDA Approval of Supplemental New Drug Application for SOLOSEC® (secnidazole) for the Treatment of Trichomoniasis lupin.com ↗
Lupin Pharmaceuticals, Inc. (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application to expand the use of SOLOSEC® (secnidazole) to include the treatment of trichomoniasis in adults. |
| 2020-11-16 | Lupin Limited | Regulatory Lupin Announces FDA Filing Acceptance of Supplemental New Drug Application for Solosec® (secnidazole) for the Treatment of Trichomoniasis lupin.com ↗ |
| 2020-08-14 | Lupin Limited | Results Lupin Presents Phase 3 Data for Solosec® (secnidazole) Demonstrating Significant Response Rate in Female Patients with Trichomoniasis lupin.com ↗
The trial results showed a clinically and statistically significant response rate, or microbiological cure, in patients treated with Solosec® as compared to placebo (p<0.001). |
| 2020-05-04 | Lupin Limited | Results Lupin Announces Positive Topline Results from its Phase 3 Study of Single-Dose Solosec® (secnidazole) for the Treatment of Trichomoniasis lupin.com ↗
The trial demonstrated a clinically and statistically significant response rate, or microbiological cure, in patients dosed with Solosec® as compared to placebo (p<0.001). |
All press releases naming this drug 14 releases
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Secnidazole | “Multi-center, Prospective, Open-Label Study to Evaluate the Safety of A Single Dose of SYM-1219, a Granule Formulation Containing 2 Grams of Secnidazole, for the Treatment of...” NCT02452866 ↗ |
| Known as | Deprozol | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Flagentyl | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | NSC-759812 | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Ornidazole metabolite m4 | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | PM-185184 | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | RP 14539 | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Sabima | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Secnidal | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Secnidazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Secnidazole anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Secnol | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | Solosec | ChEMBL registry synonym — accepted as the source's own label CHEMBL498847 ↗ |
| Known as | SYM-1219 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02147899 ↗ |
| Modality | Small molecule | “a next generation 5-nitroimidazole” PMID 42031495 ↗ Apr 2026 |
| Route | Oral | “a single oral dose of a combined treatment with secnidazole + fluconazole” NCT02111629 ↗ |