Posaconazole

Overview

Posaconazole is a triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients.

Indication

For prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised as a result of procedures such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD), or due to hematologic malignancies with prolonged neutropenia from chemotherapy. Also for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole. Posaconazole is used as an alternative treatment for invasive aspergillosis, Fusarium infections, and zygomycosis in patients who are intolerant of, or whose disease is refractory to, other antifungals.

Associated Conditions

Candidiasis
Coccidioidomycosis
Esophageal Candidiasis
Fungal Infections
Invasive Aspergillosis
Invasive bronchopulmonary aspergillosis
Mucormycosis
Oropharyngeal Candidiasis
Prophylaxis of Aspergillus infection
Pulmonary cryptococcosis infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Posaconazole Plus Pembrolizumab and Chemotherapy vs Pembrolizumab and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer	2025/01/31	NCT06802757	Phase 2	Recruiting	Shandong Cancer Hospital and Institute
Posaconazole Tablet As Primary Prophylaxis of HSCT Patients with Gastrointestinal GVHD	2024/11/20	NCT06698211	N/A	ENROLLING_BY_INVITATION	Institute of Hematology & Blood Diseases Hospital, China
Study of Posaconazole Prophylaxis in Patients Receiving Hematopoietic Stem Cell Allograft (allo-HSC) At High Risk of Invasive Fungal Infection (IFI)	2024/08/07	NCT06541067	Phase 2	Recruiting	Nantes University Hospital
Amphotericin Versus Posaconazole for Pulmonary Mucormycosis	2022/07/21	NCT05468372	Phase 2	Recruiting	Post Graduate Institute of Medical Education and Research, Chandigarh
Posaconazole Prophylaxis for CAPA Prevention in Critically-Ill Patients	2021/10/04	NCT05065658	N/A	Completed	Medical University of Graz
Pilot Study of Posaconazole in Crohn's Disease	2021/07/19	NCT04966585	Phase 4	Terminated	Cedars-Sinai Medical Center
A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection	2021/07/19	NCT04966234	Phase 2	UNKNOWN	Bambino Gesù Hospital and Research Institute
Neuro-pharmacological Properties of Repurposed Posaconazole in Glioblastoma: a Phase 0 Clinical Trial	2021/04/01	NCT04825275	Early Phase 1	Terminated	Milton S. Hershey Medical Center
A Study of BGB-11417 in Participants With Myeloid Malignancies	2021/02/25	NCT04771130	Phase 1	Recruiting	BeiGene
Posaconazole for Pulmonary Fungal Infection Prophylaxis in Hematopoietic Stem Cell Transplantation Patients	2021/01/27	NCT04725942	N/A	UNKNOWN	Institute of Hematology & Blood Diseases Hospital, China

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
POSACONAZOLE	ATLANTIC BIOLOGICALS CORP.	17856-2133	ORAL	100 mg in 1 1	3/1/2022
NOXAFIL	Merck Sharp & Dohme LLC	0085-4331	INTRAVENOUS	18 mg in 1 mL	10/20/2023
POSACONAZOLE	Eugia US LLC	55150-388	INTRAVENOUS	18 mg in 1 mL	4/20/2022
posaconazole	Hikma Pharmaceuticals USA Inc.	0054-0449	ORAL	40 mg in 1 mL	3/7/2022
Posaconazole	AvKARE	42291-919	ORAL	100 mg in 1 1	4/25/2023
Posaconazole	Par Pharmaceutical, Inc.	42023-195	INTRAVENOUS	18 mg in 1 mL	6/2/2022
NOXAFIL	Merck Sharp & Dohme LLC	0085-2224	ORAL	300 mg in 1 1	10/20/2023
POSACONAZOLE	Cardinal Health 107, LLC	55154-4322	ORAL	100 mg in 1 1	9/27/2023
Posaconazole	A2A Integrated Pharmaceuticals	73141-023	ORAL	100 mg in 1 1	2/28/2025
NOXAFIL	Merck Sharp & Dohme LLC	0085-4324	ORAL	100 mg in 1 1	10/20/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Posaconazole Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	7/25/2019
Noxafil	Merck Sharp and Dohme B.V,Waarderweg 39,2031 BN Haarlem,The Netherlands	Authorised	10/25/2005
Posaconazole AHCL	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	7/25/2019

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
POSACONAZOLE SANDOZ GASTRO-RESISTANT TABLETS 100MG	Catalent Pharma Solutions LLC, Lek Pharmaceuticals d.d. (Primary and Secondary Packager)	SIN15897P	TABLET, DELAYED RELEASE	100.00 mg	3/9/2020
NOXAFIL TABLET 100MG	N. V. Organon	SIN15045P	TABLET, DELAYED RELEASE	100mg	7/5/2016
NOXAFIL ORAL SUSPENSION 40 mg/ml	Patheon Inc.	SIN13654P	SUSPENSION	40mg/ml	5/25/2009
SINOTRX POSACONAZOLE DELAYED RELEASE TABLET 100MG	HAIMEN PHARMA INC	SIN16477P	TABLET, DELAYED RELEASE	100 mg	4/13/2022
POSATIF POSACONAZOLE GASTRO-RESISTANT TABLETS 100MG	AET Laboratories Pvt. Ltd	SIN17200P	TABLET, DELAYED RELEASE	100 mg	3/10/2025

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Posaconazole Oral Suspension	湖南科伦制药有限公司	国药准字H20233242	化学药品	口服混悬剂	2/28/2023
Posaconazole Oral Suspension	Merck Sharp & Dohme BV	国药准字HJ20181110	化学药品	口服混悬剂	11/18/2022
Posaconazole Enteric-coated Tablets	浙江华海药业股份有限公司	国药准字H20253931	化学药品	片剂	4/15/2025
Posaconazole Enteric-coated Tablets	齐鲁制药（海南）有限公司	国药准字H20233928	化学药品	片剂	7/11/2023
Posaconazole Enteric-coated Tablets	HETERO LABS LIMITED	国药准字HJ20240139	化学药品	片剂	12/1/2024
Posaconazole Enteric-coated Tablets	康缘华威医药有限公司	国药准字H20243431	化学药品	片剂	4/7/2024
Posaconazole Enteric-coated Tablets	四川科伦药业股份有限公司	国药准字H20223729	化学药品	片剂	11/9/2022
Posaconazole Enteric-coated Tablets	浙江海正药业股份有限公司	国药准字H20244926	化学药品	片剂	9/19/2024
Posaconazole Enteric-coated Tablets	江西山香药业有限公司	国药准字H20233962	化学药品	片剂	7/25/2023
Posaconazole Enteric-coated Tablets	江苏海岸药业有限公司	国药准字H20243033	化学药品	片剂	1/9/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NOXAFIL posaconazole 300 mg/16.7 mL concentrated injection vial	218702	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	1/27/2015
APX-POSACONAZOLE posaconazole 40 mg/mL oral suspension bottle	383454	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/18/2023
NOXAFIL posaconazole 100mg modified release tablets blister pack	216283	Merck Sharp & Dohme (Australia) Pty Ltd	Medicine	A	11/27/2014
PHARMACOR POSACONAZOLE posaconazole 100 mg modified release tablet bottle pack	328101	Pharmacor Pty Ltd	Medicine	A	11/12/2020
AXOFIL posaconazole 100 mg modified release tablet blister pack	328105	Pharmacor Pty Ltd	Medicine	A	11/12/2020
POSACONAZOLE-DRLA posaconazole 100 mg modified release tablet blister pack	317442	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	7/24/2020
POSACONAZOLE SUSPENSION ARX posaconazole 40 mg/mL oral suspension bottle	383452	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	1/18/2023
AKM POSACONAZOLE posaconazole 100 mg modified release tablet blister pack	328103	Pharmacor Pty Ltd	Medicine	A	11/12/2020
AKM POSACONAZOLE posaconazole 100 mg modified release tablet bottle pack	328100	Pharmacor Pty Ltd	Medicine	A	11/12/2020
POSACONAZOLE-REDDY'S posaconazole 100 mg modified release tablet blister pack	317445	Dr Reddys Laboratories Australia Pty Ltd	Medicine	A	7/24/2020

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