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Sporanox
Sporanox is a Small molecule drug developed by Mayne Pharma International Pty Ltd. It is currently FDA-approved. Also known as: itraconazole.
Sporanox, also known as itraconazole, is an antifungal medication used to treat various fungal infections, including aspergillosis, blastomycosis, coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. It works by inhibiting the enzyme lanosterol 14-alpha demethylase through its action as a cytochrome P450 51 inhibitor.
At a glance
| Generic name | Sporanox |
|---|---|
| Also known as | itraconazole |
| Sponsor | Mayne Pharma International Pty Ltd |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- BOXED WARNING Congestive Heart Failure, Cardiac Effects and Drug Interactions Congestive Heart Failure and Cardiac Effects SPORANOX ® (itraconazole) Capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF. If signs or symptoms of congestive heart failure occur during administration of SPORANOX ® Capsules, discontinue administration. When itraconazole was administered int
Common side effects
- Headache
- Rhinitis
- Upper respiratory tract infection
- Sinusitis
- Injury
- Diarrhea
- Dyspepsia
- Flatulence
- Abdominal pain
- Dizziness
- Rash
- Cystitis
Serious adverse events
- Hepatic failure
- Liver failure
- Cardiac failure
- Left ventricular failure
- Hepatotoxicity
- Jaundice
- Hyperbilirubinemia
- Renal impairment
- Confusional state
- Tachycardia
Key clinical trials
- Evaluation of VX-828 in Healthy Participants and in Participants With Cystic Fibrosis (PHASE1)
- A Clinical Trial in Healthy Participants to Learn How Itraconazole Affects MK-2828 Levels and How MK-2828 Affects Midazolam Levels (MK-2828-007) (PHASE1)
- A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants (PHASE1)
- Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole (PHASE1)
- A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 764198 in the Blood (PHASE1)
- Itraconazole in Combination With Ablation for the Prevention of Esophageal Cancer in Patients With High-risk Barrett's Esophagus (PHASE2)
- A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine) (PHASE1)
- A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (PHASE1)
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 |
|---|---|
| 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:
- Sporanox CI brief — competitive landscape report
- Sporanox updates RSS · CI watch RSS
- Mayne Pharma International Pty Ltd portfolio CI
Frequently asked questions about Sporanox
What is Sporanox?
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Is Sporanox also known as anything else?
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What are the side effects of Sporanox?
Related
- Manufacturer: Mayne Pharma International Pty Ltd — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: itraconazole
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing