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Ancobon (FLUCYTOSINE)
Ancobon (Flucytosine) is a nucleoside analog antifungal medication developed by Valeant and currently owned by Bausch. It targets the 5-hydroxytryptamine receptor 2A and works by inhibiting fungal DNA synthesis. Ancobon is approved to treat various fungal infections, including candidal urinary tract infections and systemic cryptococcosis. The medication is available as a generic product, off-patent, and has a bioavailability of 84% with a half-life of 4.2 hours. Key safety considerations include monitoring for bone marrow suppression and hepatotoxicity.
At a glance
| Generic name | FLUCYTOSINE |
|---|---|
| Sponsor | Bausch Health |
| Drug class | Nucleoside Analog Antifungal [EPC] |
| Target | 5-hydroxytryptamine receptor 2A |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1971 |
Approved indications
- Serious Candida Infections
- Candida Pulmonary Infections
- Cryptococcus Meningitis
- Cryptococcus Pulmonary Infections
- Cryptococcus Septicemia
- Cryptococcus Urinary Tract Infections
Boxed warnings
- WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of Flucytosine Capsules USP.
Common side effects
- Hepatic necrosis
- Renal failure
- Bone marrow aplasia
- Gastrointestinal hemorrhage
- Acute hepatic injury
- Hepatic dysfunction
- Jaundice
- Ulcerative colitis
- Enterocolitis
- Bilirubin elevation
- Increased hepatic enzymes
- Cardiac arrest
Drug interactions
- Cytosine arabinoside
- Drugs which impair glomerular filtration
Key clinical trials
- DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade Glioma (PHASE1,PHASE2)
- Platform Trial For Cryptococcal Meningitis (PHASE2,PHASE3)
- Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST) (PHASE3)
- Optimizing the Dose of Flucytosine for the Treatment of Cryptococcal Meningitis (PHASE2)
- DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma (PHASE2)
- Clinical Study on the Safety and Efficacy of Novel Oncolytic Virus in the Treatment of Recurrent Malignant Glioma (PHASE1,PHASE2)
- Amphotericin B for Non-HIV Cryptococcal Meningitis Patients (PHASE4)
- Study of Intrahepatic Arterial Infusion of TG6002 in Combination With 5-FC in Patients With Metastatic Colorectal Cancer (PHASE1,PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ancobon CI brief — competitive landscape report
- Ancobon updates RSS · CI watch RSS
- Bausch Health portfolio CI