CIDOFOVIR ANHYDROUS
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cytomegalovirus retinitis 1 milestone | |||||
| Filed | EU (EMA) | VISTIDE | cytomegalovirus retinitis | — | “In December of 1995 Gilead filed a marketing authorization for VISTIDE with the European Community's Committee for Proprietary Medicinal Products.” gilead.com ↗ |
| Rejected varicella, severe recurrent 1 milestone | |||||
| Rejected (CRL) | US (FDA) | FORVADE | varicella, severe recurrent | 1997-05-06 | “FDA has determined that data from a placebo-controlled Phase I/II clinical study are not sufficient to support marketing clearance of FORVADE TM (cidofovir gel)” gilead.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| Withdrawn | EU (EMA) | Vistide | — | 2014-08-22 | europa.eu ↗ |
| Label expansion | US (FDA) | VISTIDE | — | 1999-03-09 | fda.gov ↗ |
| Approved | EU (EMA) | Vistide | — | 1997-04-23 | europa.eu ↗ |
| Approved | US (FDA) | VISTIDE | — | 1996-06-26 | fda.gov ↗ |
Trials 28
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 1998-03-10 | Gilead Sciences | Results Cidofovir Reported to Have Activity Against Poxvirus Infection in Primates gilead.com ↗
In primates infected with monkeypox, cidofovir treatment reduced respiratory symptoms, fever and pox-like skin lesions and decreased mortality associated with the viral infection. |
| 1997-05-06 | Gilead Sciences | Regulatory Gilead Announces Phase I/II Data Insufficient for Marketing Clearance of FORVADETM Topical Gel to Treat Refractory Herpes in Patients with AIDS gilead.com ↗ |
| 1997-05-01 | Gilead Sciences | Regulatory Gilead Sciences Receives Marketing Authorization for VISTIDE® in European Union gilead.com ↗
Gilead Sciences, Inc. (NASDAQ:GILD) announced today that it has received marketing authorization for VISTIDE (cidofovir injection) from the European Commission (EC). |
| 1996-12-20 | Gilead Sciences | Regulatory Pharmacia & Upjohn and Gilead Sciences Receive European Recommendation for VISTIDE® gilead.com ↗ |
| 1996-06-27 | Gilead Sciences | Regulatory FDA Grants Marketing Clearance of Gilead's VISTIDE® for the Treatment of CMV Retinitis in Patients with AIDS gilead.com ↗
Gilead Sciences Inc. (NASDAQ:GILD) today announced that the U.S. Food and Drug Administration (FDA) granted marketing clearance of VISTIDE (cidofovir injection) for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS. |
All press releases naming this drug 7 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CIDOFOVIR ANHYDROUS | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate | “A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory...” NCT00002116 ↗1“Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum” NCT00002327 ↗ |
| Known as | Anhydrous cidofovir | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | Cidofovir | “The investigators have previously shown that antiviral agents used in preclinical models, Cidofovir® causes the selective radiosensitization of cells infected by the...” NCT02515877 ↗32“Cidofovir iv infusion of 5 mg/kg body weight given once weekly, or Cidofovir 1% or 3% topical treatment” NCT03073967 ↗ |
| Known as | Cidofovir dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | Forvade | “The purpose of this study is to see if cidofovir gel (Forvade) is safe and effective in treating herpes simplex in patients with AIDS who do not respond to acyclovir.” NCT00002181 ↗ |
| Known as | GS-0504 | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | HPMPC | “A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory...” NCT00002116 ↗5“A Phase II/III Study of the Safety and Efficacy of 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) for the Treatment of Peripheral...” NCT00002437 ↗ “To evaluate short-term and long-term safety and efficacy of intravenous cidofovir (HPMPC) for treatment of small peripheral cytomegalovirus (CMV) retinitis lesions.” NCT00000799 ↗ “To test and evaluate the efficacy and safety of intravenous cidofovir (Vistide, previously known as HPMPC) for the treatment of retinitis.” NCT00000142 ↗ “To evaluate the safety and tolerance of cidofovir (HPMPC) infusions in AIDS patients with relapsing cytomegalovirus (CMV) retinitis.” NCT00002142 ↗ “Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Condyloma Acuminatum” NCT00002327 ↗ |
| Known as | Hpmpc dihydrate | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | NSC-742135 | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Known as | Vistide | ChEMBL registry synonym — accepted as the source's own label CHEMBL152 ↗ |
| Modality | Small molecule | — CHEMBL152 ↗ |
| Route | Intravenous | “Cidofovir is administered as an intravenous infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy.” NCT00000142 ↗ |