Solosec

(Secnidazole)

Phase 3Small molecule

EEvofem Inc.

Solosec is one of 2 small molecule programs targeting Trichomoniasis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

TrichomoniasisActive, not recruiting

TrichomoniasisPhase 3

Active, not recruiting

Competition

Competitive Landscape

2 competitors in Trichomoniasis

#DrugCompanyPhaseTrials

Flagyl

DDePuy Orthopaedics

Phase 2

1 2

Solosec

EEvofem Inc.

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2029

Post-ApprovalRecruiting

Treatment

NCT06261840

Clinical

Trials by Indication[1]

Adolescent1 trial

Evaluate the Safety of a Single Oral Dose of Solosec™ (Secnidazole) 2g for the Treatment of Adolescent Girls With BV

Completed·LLupin Research Inc·Phase 4·NCT03937869·40 enrolled

Treatment1 trial

Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronidazole and Secnidazole

Recruiting·TTulane University·Phase 4·NCT06261840·1,200 enrolled

Trichomoniasis1 trial

A Phase 3 Study of Solosec® for the Treatment of Trichomoniasis

Completed·LLupin Research Inc·Phase 3·NCT03935217·147 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 15, 2017

SOLOSEC

NDA NDA209363

Sources

References

[1]
ClinicalTrials.gov — 3 trial records for Secnidazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Secnidazole compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Secnidazole. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209363). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Solosec. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Evofem Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: EEvofem Inc.

Patent Landscape[5]

Patent Cliff

Sep 4, 2035

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11324721Sep 4, 2035

11602522Sep 4, 2035

10335390Sep 4, 2035

11000507Sep 4, 2035

11020377Sep 4, 2035

6 more patents

11000508Sep 4, 2035

10682338Sep 4, 2035

10849884Sep 4, 2035

10857133Sep 4, 2035

11684607Sep 16, 2035

12280037Dec 11, 2041

Solosec

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2029

Trials by Indication[1]

Adolescent1 trial

Treatment1 trial

Trichomoniasis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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