Noxafil

(Posaconazole)

ApprovedSmall molecule

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Posaconazole is used to prevent and treat serious fungal infections, particularly in people with weakened immune systems such as those undergoing chemotherapy or organ transplants.[2] Noxafil is currently approved and in use across 18 indications[4].[1]

Noxafil is one of 290 small molecule programs targeting Chromoblastomycosis. It is currently in Approved.

Indications

Total Trials

Active Trials

289

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

ChromoblastomycosisActive, not recruiting

Fungal Lung Infectious DiseaseActive, not recruiting

MucormycosisActive, not recruiting

Eumycotic MycetomaActive, not recruiting

NeutropeniaActive, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmActive, not recruiting

FusariosisActive, not recruiting

Fungal Infectious DiseaseActive, not recruiting

Tinea UnguiumApproved

Glioblastoma MultiformeApproved

ChromoblastomycosisApproved

Active, not recruiting

Fungal Lung Infectious DiseasePreclinical

Active, not recruiting

MucormycosisApproved

Active, not recruiting

Eumycotic MycetomaApproved

Active, not recruiting

NeutropeniaApproved

Active, not recruiting

Hematopoietic and Lymphoid Cell NeoplasmApproved

Active, not recruiting

FusariosisApproved

Active, not recruiting

Fungal Infectious DiseaseApproved

Active, not recruiting

Tinea UnguiumApproved

Approved

Glioblastoma MultiformeApproved

Approved

Showing 10 of 18 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Noxafil

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Acupan

YYonsei University

Preclinical

1 6

Paracetamol

GSK

Preclinical

1 7

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 8

Ablavar

LLantheus Medical Imaging

Preclinical

2 9

Metfomin

UUniversity of Texas Southwestern Medical Center

Preclinical

1 10

Dextromethorphan Hydrobromide

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q2 2027

Phase 2Recruiting

Invasive Fungal Infection

NCT04665037

Phase 1Not yet recruiting

Glioma

NCT03763396

Q4 2027

N/ARecruiting

Prophylaxis

NCT03828773

Q1 2028

Phase 2Recruiting

Breast Cancer

NCT06802757

Q3 2028

PreclinicalRecruiting

Acute Myeloid Leukemia

NCT04771130

Clinical

Trials by Indication[1]

Invasive Fungal Infections11 trials

Posaconazole to Treat Invasive Fungal Infections

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00033982·50 enrolled

Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension in Subjects at High Risk for Invasive Fungal Infections (P05520)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01075984·279 enrolled

Pharmacokinetics and Safety of Posaconazole Tablet in Participants at High Risk for Invasive Fungal Infections (MK-5592-065/P05615)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01777763·230 enrolled

Show 8 more trials

Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00034632

PK/PD Study of Posaconazole for Empiric Treatment of Invasive Fungal Infections in Neutropenic Patients or Treatment of Refractory Invasive Fungal Infections (Study P01893)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00034671·98 enrolled

Limited Access Protocol of Posaconazole in Invasive Fungal Infections Study PO2095

Terminated·UUniversity of Pittsburgh·Phase 4·NCT00177749·10 enrolled

Pharmacokinetics and Safety of Intravenous Posaconazole (MK-5592) in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-120)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT03336502·70 enrolled

Pharmacokinetics of Posaconazole (Noxafil®) as Prophylaxis for Invasive Fungal Infections

Completed·RRadboud University Medical Center·Phase 4·NCT02805946·21 enrolled

Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT02387983·65 enrolled

Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00034658·336 enrolled

Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)

Approved for marketing· Merck & Co. logo

Merck & Co.··NCT00686621

Prophylaxis4 trials

PTX3-targeted Antifungal Prophylaxis

Recruiting·BBochud Pierre-Yves·N/A·NCT03828773·410 enrolled

Prophylaxis Trial of Posaconazole Versus Standard Azole Therapy for Neutropenic Patients (Study P01899)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00044486·602 enrolled

Posaconazole Prophylaxis During ATG Treatment for hMDS/AA Patients

Completed·SSeoul National University Hospital·Phase 2·NCT03318159·20 enrolled

Show 1 more trial

Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients

Completed·MMedical University of Graz··NCT05065658·249 enrolled

Invasive Fungal Infection4 trials

Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00811642·63 enrolled

Safety and Efficacy Study of Posaconazole vs. Fluconazole for Prevention of Invasive Fungal Infection (P05387 AM1)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00811928·252 enrolled

Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (Allo-HSC) at High Risk of Invasive Fungal Infection (IFI)

Recruiting·NNantes University Hospital·Phase 2·NCT06541067·30 enrolled

Show 1 more trial

A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formulations in Pediatric Participants From Birth to Less Than 2 Years of Age With Possible, Probable, or Proven Invasive Fungal Infection

Recruiting· Merck & Co. logo

Merck & Co.·Phase 2·NCT04665037·40 enrolled

Aspergillosis3 trials

A Study of the Safety and Efficacy of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis (MK-5592-069)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT01782131·585 enrolled

Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT04218851·31 enrolled

King's Invasive Aspergillosis Study II

Completed·KKing's College Hospital NHS Trust·Phase 4·NCT02875743·120 enrolled

Acute Myeloid Leukemia3 trials

Pharmacokinetics Variability of Posaconazole (PCZ) and Its Glucuronide Metabolite During Induction and Consolidation Treatments in Patients With Acute Myeloid Leukemia (AML): a Covariate Analysis With the Tablets Formulation and Evaluation of the Potential Risk of Hepatotoxicity

Unknown status·HHospices Civils de Lyon·N/A·NCT03796533·120 enrolled

A Phase 1b/2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies

Recruiting· BeiGene logo

BeiGene·Preclinical·NCT04771130·260 enrolled

A Phase 1/2, Open Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination With Other Antileukemic Agents in Participants With Selected Myeloid Malignancies

Not yet recruiting·SServier·Preclinical·NCT07719348·64 enrolled

39 more indications

Chagas disease2 trials

Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole

Completed·HHospital Universitari Vall d'Hebron Research Institute·Phase 2·NCT01162967·78 enrolled

A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT01377480·120 enrolled

Cystic Fibrosis2 trials

A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection

Unknown status·—·Phase 2/3·NCT04966234·135 enrolled

Modified Release Posaconazole in Patients With Cystic Fibrosis

Unknown status·BBayside Health··NCT03421366·20 enrolled

Patients With Solid Tumors1 trial

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

Completed· Roche logo

Roche·Phase 1·NCT01901172·61 enrolled

Drug Interactions1 trial

Drug/Drug Interactions With F901318

Withdrawn·FF2G Biotech GmbH·Phase 1·NCT03095547

Newly Diagnosed1 trial

HDM201 Added to CT in R/R or Newly Diagnosed AML

Withdrawn· Novartis logo

Novartis·Phase 1/2·NCT03760445

Leukemia1 trial

Study of ABT-199 (GDC-0199) in Combination With Azacitidine or Decitabine (Chemo Combo) in Subjects With Acute Myelogenous Leukemia (AML)

Terminated· AbbVie logo

AbbVie·Phase 1·NCT02203773·212 enrolled

Crohn's Disease1 trial

Pilot Study of Posaconazole in Crohn's Disease

Terminated·—·Phase 4·NCT04966585·10 enrolled

Gastrointestinal1 trial

Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD

Enrolling by invitation·IInstitute of Hematology & Blood Diseases Hospital, China··NCT06698211·40 enrolled

Chronic Granulomatous Disease1 trial

Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)

Completed·RRadboud University Medical Center·Phase 2·NCT00799071·12 enrolled

Obese1 trial

Dosing Obese With Noxafil® Under a Trial (DONUT)

Completed·RRadboud University Medical Center·Phase 4·NCT03246386·24 enrolled

Transplant Recipient1 trial

Prophylaxis Trial in High Risk Allogenic Stem Cell Transplant Recipients With Graft vs. Host Disease

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00034645·600 enrolled

Glioma1 trial

Azoles Targeting Recurrent High Grade Gliomas

Not yet recruiting·UUniversity Health Network, Toronto·Phase 1·NCT03763396·30 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients

Completed·IInstitute of Hematology & Blood Diseases Hospital, China··NCT04725942·360 enrolled

Oral1 trial

Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)

Completed·MM.D. Anderson Cancer Center·Phase 3·NCT00750737·46 enrolled

Gastrointestinal Dysfunction1 trial

Oral Posaconazole in High Risk Patients With Gastrointestinal Dysfunction (Study P05115)

Completed· Merck & Co. logo

Merck & Co.·Phase 4·NCT00686543·75 enrolled

Systemic1 trial

Registry of Patients Treated With Systemic Mold-Active Triazoles

Completed· Astellas logo

Astellas··NCT03066011·2,015 enrolled

Effectiveness1 trial

Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients

Completed·SSchering-Plough·Phase 3·NCT00002446·300 enrolled

Acute Leukemia1 trial

Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT00936117·25 enrolled

Inflammation1 trial

Effect of Inflammation on Pharmacokinetics of Posaconazole

Completed·UUniversity Medical Center Groningen··NCT02492802·64 enrolled

Infection1 trial

Posaconazole as Salvage Therapy for Aspergillus Pulmonary Infection.

Withdrawn·TTaichung Veterans General Hospital·Phase 4·NCT02020213

Chronic Graft Versus Host Disease1 trial

Front Line Ibrutinib Without Corticosteroids for Newly Diagnosed Chronic Graft-versus-Host Disease

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04294641·10 enrolled

Breast Cancer1 trial

Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

Recruiting·SShandong Cancer Hospital and Institute·Phase 2·NCT06802757·72 enrolled

Safety and Efficacy1 trial

Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT02180165·116 enrolled

OSA1 trial

Post-marketing Surveillance Study of Invasive Mycosis With Posaconazole (Study P04641)

Completed· Merck & Co. logo

Merck & Co.··NCT00726609·214 enrolled

Tics1 trial

A Study of the Effects of Posaconazole on Alectinib (RO5424802) Pharmacokinetics in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01984229·23 enrolled

Critically Ill Patients1 trial

Single Dose Population Pharmacokinetics of Intravenous Posaconazole in Critically Ill Patients

Completed·—·Phase 4·NCT02968134·8 enrolled

MPR1 trial

Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir

Completed·RRadboud University Medical Center·Phase 1·NCT00817765·24 enrolled

Lung Transplant Recipient1 trial

A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)

Terminated· Merck & Co. logo

Merck & Co.·Phase 4·NCT01667107·26 enrolled

Interaction1 trial

Pharmacokinetics (PK) Drug Interaction Study of Milademetan and Itraconazole or Posaconazole in Healthy Participants

Completed· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT03614455·36 enrolled

Efficacy and Safety1 trial

A Study to Examine the Efficacy and Safety of Posaconazole When Introduced Early in the Treatment of Refractory Fungal Infections (P05090 AM2)

Completed· Merck & Co. logo

Merck & Co.·Phase 2·NCT00550732·40 enrolled

Invasive Fungal Disease1 trial

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation

Active, not recruiting·MMundipharma Research Limited·Phase 3·NCT04368559·602 enrolled

Myelodysplastic Syndrome1 trial

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

Completed·MMemorial Sloan Kettering Cancer Center·Phase 4·NCT01200355·113 enrolled

Children1 trial

Genetic Variation and Variability in Posaconazole Pharmacokinetics in Children

Completed·—·Phase 1·NCT02358499·31 enrolled

Candidiasis1 trial

A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

Completed·SSchering-Plough·Phase 2·NCT00002399·500 enrolled

Coccidioidomycosis1 trial

POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT00423267·16 enrolled

Histoplasmosis1 trial

Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT)

Not yet recruiting·UUniversity of Minnesota·Phase 3·NCT07261150·664 enrolled

Acute Myeloid Leukaemia1 trial

A Phase 1, Open-Label, Multi-Centre Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of AMX-883 Monotherapy in Participants With Acute Myeloid Leukaemia and High-Risk Myelodysplastic Syndrome and in Combination With Anticancer Agents in Participants With Acute Myeloid Leukaemia

Recruiting·AAmphista Therapeutics Ltd·Phase 1·NCT07723703·54 enrolled

Acute Myeloid Leukemia (AML)1 trial

Phase 1b Study of Monzosertib In Patients With Relapsed Or Refractory Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07780565·42 enrolled

Acute Lymphoblastic Leukaemia1 trial

A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy 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

Recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT07155226·84 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 15, 2006

NOXAFIL

NDA NDA022003

Nov 25, 2013

NOXAFIL

NDA NDA205053

Mar 13, 2014

NOXAFIL

NDA NDA205596

May 31, 2021

NOXAFIL POWDERMIX KIT

NDA NDA214770

Sources

References

[1]
ClinicalTrials.gov — 66 trial records for Posaconazole. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Noxafil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Posaconazole compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Posaconazole. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214770). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Noxafil. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Cytochrome P450 51 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Patent Landscape[6]

Patent Cliff

Mar 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10117951Mar 13, 2029

9358297Jun 24, 2031

9023790Jul 4, 2031

Noxafil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q4 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Invasive Fungal Infections11 trials

Prophylaxis4 trials

Invasive Fungal Infection4 trials

Aspergillosis3 trials

Acute Myeloid Leukemia3 trials

Chagas disease2 trials

Cystic Fibrosis2 trials

Patients With Solid Tumors1 trial

Drug Interactions1 trial

Newly Diagnosed1 trial

Leukemia1 trial

Crohn's Disease1 trial

Gastrointestinal1 trial

Chronic Granulomatous Disease1 trial

Obese1 trial

Transplant Recipient1 trial

Glioma1 trial

Hematopoietic Stem Cell Transplantation1 trial

Oral1 trial

Gastrointestinal Dysfunction1 trial

Systemic1 trial

Effectiveness1 trial

Acute Leukemia1 trial

Inflammation1 trial

Infection1 trial

Chronic Graft Versus Host Disease1 trial

Breast Cancer1 trial

Safety and Efficacy1 trial

OSA1 trial

Tics1 trial

Critically Ill Patients1 trial

MPR1 trial

Lung Transplant Recipient1 trial

Interaction1 trial

Efficacy and Safety1 trial

Invasive Fungal Disease1 trial

Myelodysplastic Syndrome1 trial

Children1 trial

Candidiasis1 trial

Coccidioidomycosis1 trial

Histoplasmosis1 trial

Acute Myeloid Leukaemia1 trial

Acute Myeloid Leukemia (AML)1 trial

Acute Lymphoblastic Leukaemia1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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