MedPath

Cidofovir

Generic Name
Cidofovir
Brand Names
Vistide
Drug Type
Small Molecule
Chemical Formula
C8H14N3O6P
CAS Number
113852-37-2
Unique Ingredient Identifier
768M1V522C

Overview

Cidofovir is an injectable antiviral medication employed in the treatment of cytomegalovirus (CMV) retinitis in patients diagnosed with AIDS. It suppresses CMV replication through selective inhibition of viral DNA synthesis. It was manufactured by Gilead and initially approved by the FDA in 1996, but has since been discontinued.

Background

Cidofovir is an injectable antiviral medication employed in the treatment of cytomegalovirus (CMV) retinitis in patients diagnosed with AIDS. It suppresses CMV replication through selective inhibition of viral DNA synthesis. It was manufactured by Gilead and initially approved by the FDA in 1996, but has since been discontinued.

Indication

用于治疗免疫功能缺陷患者不能耐受更昔洛韦和膦甲酸钠治疗或治疗无效的巨细胞病毒感染。

Associated Conditions

  • Cytomegalovirus Retinitis
  • Herpes Simplex Virus
  • Monkeypox
  • Variola Major (Smallpox)

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2019/08/13
Phase 3
Completed
2016/11/30
Phase 2
Completed
2016/10/13
Phase 3
Completed
2015/10/02
Phase 2
Withdrawn
2015/09/22
Phase 2
UNKNOWN
Centro de Investigación en. Enfermedades Infecciosas, Mexico
2015/08/05
Phase 1
Completed
2013/09/19
Not Applicable
Completed
2013/03/22
Phase 1
Completed
2011/02/14
Phase 2
Active, not recruiting
2009/10/05
Phase 1
Completed
Mithra Pharmaceuticals

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Mylan Institutional LLC
67457-210
INTRAVENOUS
75 mg in 1 mL
2/25/2020
Gilead Sciences, Inc.
61958-0101
INTRAVENOUS
75 mg in 1 mL
9/24/2013
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
23155-216
INTRAVENOUS
375 mg in 5 mL
4/21/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

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
EMPOVIR cidofovir 375 mg/5 mL concentrated injection for infusion vial
287040
Medicine
A
4/4/2018
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