Viroptic

(Trifluridine)

PreclinicalSmall molecule

MMonarch Medical Research

Viroptic is one of 2 small molecule programs targeting Mycobacterium. It is currently in Preclinical.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

MycobacteriumCompleted

MycobacteriumPreclinical

Completed

Competition

Competitive Landscape

2 competitors in Mycobacterium

#DrugCompanyPhaseTrials

Arikayce

IInsmed Incorporated

Phase 2

1 2

Viroptic

MMonarch Medical Research

Preclinical

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

Timeline

Expected Milestones

Q2 2029

Phase 1Recruiting

Ewing Sarcoma

NCT03715933

Clinical

Trials by Indication[1]

Mycobacterium1 trial

Evaluation of the Therapeutic Benefit of r-metHuIFN- Gamma in AIDS Patients With Disseminated Mycobacterium Avium-Intracellulare (MAI) Infection: A Multi-Centered Pilot Study

Completed· Amgen logo

Amgen·N/A·NCT00002037·15 enrolled

Metastatic Colorectal Cancer1 trial

A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations

Terminated·KKaryopharm Therapeutics Inc·Phase 2·NCT04854434·13 enrolled

Tics1 trial

Study Comparing the Pharmacokinetics of FTD as a Component of TAS-102 With FTD Alone

Completed· Taiho Oncology, Inc. logo

Taiho Oncology, Inc.·Phase 1·NCT01867866·44 enrolled

Herpes Simplex1 trial

Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00000635·25 enrolled

Ewing sarcoma1 trial

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Recruiting·IInhibrx Biosciences, Inc·Phase 1·NCT03715933·411 enrolled

2 more indications

Colorectal Carcinoma1 trial

Phase 2, Single-arm Trial of BMS-986340 in Association With Nivolumab, Trifluridine/Tipiracil and Bevacizumab for Patients Refractory to Standard of Care Treatment and With Microsatellite-stable Colorectal Cancer

Suspended·MM.D. Anderson Cancer Center·Phase 2·NCT07011550·7 enrolled

Solid Tumor1 trial

A Phase 1/2 Study of ASP1570 as Monotherapy and in Combination With Pembrolizumab and/or Standard Therapies Including Chemotherapy and/or Immunotherapy in Participants With Locally Advanced or Metastatic Solid Tumors

Terminated· Astellas logo

Astellas·Phase 1·NCT05083481·226 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

VIROPTIC

NDA NDA018299

Sources

References

[1]
ClinicalTrials.gov — 7 trial records for Trifluridine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trifluridine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Trifluridine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA018299). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Monarch Medical Research company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: MMonarch Medical Research

Viroptic

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2029

Trials by Indication[1]

Mycobacterium1 trial

Metastatic Colorectal Cancer1 trial

Tics1 trial

Herpes Simplex1 trial

Ewing sarcoma1 trial

Colorectal Carcinoma1 trial

Solid Tumor1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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