NOXAFIL (posaconazole) · Merck
Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follows: Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg Noxafil is indicated for the...
Details
- Status
- Prescription
- First Approved
- 2006-09-15
- Patent Cliff
- 2033
- Routes
- ORAL, INTRAVENOUS
- Dosage Forms
- SUSPENSION, SOLUTION, TABLET, DELAYED RELEASE
NOXAFIL Approval History
What NOXAFIL Treats
4 indicationsNOXAFIL is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Invasive Aspergillosis
- Invasive Aspergillus Infection Prophylaxis
- Invasive Candida Infection Prophylaxis
- Oropharyngeal Candidiasis
NOXAFIL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Merck's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
32 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07261150 | IDIM-2025-33491 | Ph 3 | not yet recruiting | Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT) |
| NCT07155226 MOMENTUM | D8620C00001 2025-521299-76-00 | Ph 1, Ph 2 | recruiting | Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression |
| NCT04771130 | BGB-11417-103 2021-003285-12, 2023-508881-14-00 | Ph 1, Ph 2 | recruiting | A Study of BGB-11417 in Participants With Myeloid Malignancies |
| NCT04368559 ReSPECT | CD101.IV.3.08 2017-004981-85 | Ph 3 | completed | Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation |
| NCT06802757 PRISM-TNBC | POS-PEM-Ⅱ-NEO-TNBC | Ph 2 | recruiting | Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer |
| NCT06541067 POSALLO | RC23_0186 | Ph 2 | recruiting | Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI) |
| NCT04294641 results posted | 200058 20-C-0058 | Ph 2 | completed | Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease |
| NCT03318159 results posted | H-1706-207-866 | Ph 2 | completed | Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients |
| NCT01782131 results posted | P06200 5592-069, 2011-003938-14 | Ph 3 | completed | A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069) |
| NCT02203773 | M14-358 2014-000687-18 | Ph 1 | terminated | Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML) |
| NCT02180165 results posted | 5592-101 142639, MK-5592-101 | Ph 3 | completed | Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101) |
| NCT02358499 | 1490413 | Ph 1 | completed | Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children |
| NCT00817765 EPOS | UMCN-AKF 08.03 | Ph 1 | completed | Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir |
| NCT02875743 | KIASII | Ph 4 | completed | King's Invasive Aspergillosis Study II |
| NCT03760445 | CHDM201A2101 2018-003107-19 | Ph 1, Ph 2 | withdrawn | HDM201 Added to CT in R/R or Newly Diagnosed AML |
| NCT03336502 results posted | 5592-120 MK-5992-120 | Ph 1 | completed | Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120) |
| NCT02805946 PIRAÑA | UMCN-AKF16.01 2016-001182-87 | Ph 4 | completed | Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections |
| NCT00936117 results posted | 2008-0793 | Ph 2 | completed | Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia |
| NCT02387983 results posted | 5592-117 | Ph 1 | completed | Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117) |
| NCT01667107 PAPAL results posted | 5592-105 2012-003140-68 | Ph 4 | terminated | A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105) |
| NCT02968134 POSA results posted | HREC/16/QRBW/377 | Ph 4 | completed | Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients |
| NCT01377480 STOP CHAGAS results posted | P05267 MK-5592-055 | Ph 2 | completed | A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) |
| NCT01200355 results posted | 10-038 | Ph 4 | completed | Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome |
| NCT01075984 results posted | P05520 | Ph 1 | completed | Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520) |
| NCT03095547 | F901318-01-11-17 | Ph 1 | withdrawn | Drug/Drug Interactions With F901318 |
| NCT00811642 results posted | P05551 | Ph 3 | completed | Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) |
| NCT00811928 results posted | P05387 | Ph 3 | completed | Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED) |
| NCT01984229 results posted | NP28990 | Ph 1 | completed | A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers |
| NCT00750737 results posted | 2007-0020 | Ph 3 | completed | Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) |
| NCT01901172 | NP28902 | Ph 1 | completed | A Study of the Drug-Drug Interaction of RO5503781 and Posaconazole, the Relative Bioavailability of New Formulations of RO5503781 and the Food-Effect on the Pharmacokinetics of RO5503781 in Patients With Solid Tumors |
| NCT02020213 Posaconazole | SF13263 | Ph 4 | withdrawn | Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection. |
| NCT01162967 CHAGASAZOL | CHAGASAZOL01 | Ph 2 | completed | Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
NOXAFIL FDA Label Details
Indications & Usage
FDA Label (PDF)Noxafil is an azole antifungal indicated as follows: Noxafil is indicated for the treatment of invasive aspergillosis as follows: Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of deve...
NOXAFIL Patents & Exclusivity
Patents (6 active)
Exclusivity
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Deep insights for NOXAFIL
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 13 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.