CIDOFOVIR ANHYDROUS
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Vistide | — | 2014-08-22 | europa.eu ↗ |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 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 5 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT00948506 Comparator | Jul 2009 → May 2011 | — | University of Pennsylvania | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT07387367 Comparator | Mar 2026 → Jan 2028 expected | adenoviridae infectious disease | SymBio Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT03073967 Comparator | May 2017 → Aug 2025 | herpes simplex infectious disease | AiCuris Anti-infective Cures AG | Completed | No outcome recorded |
| Phase 3 | NCT02931539 Comparator | Dec 2016 → Aug 2020 | cytomegalovirus infection | Shire | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00205374 Comparator | Nov 1999 → Dec 2009 | recurrent respiratory papillomatosis | University of Wisconsin, Madison | Completed | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-02-15 | Gilead Sciences | Gilead Issues a Voluntary Recall of One Lot of Vistide® (Cidofovir Injection) Due to Presence of Particulate Matter gilead.com ↗ |
| 1998-03-10 | Gilead Sciences | Cidofovir Reported to Have Activity Against Poxvirus Infection in Primates gilead.com ↗ |
| 1997-05-01 | Gilead Sciences | Gilead Sciences Receives Marketing Authorization for VISTIDE® in European Union gilead.com ↗ |
| 1996-12-20 | Gilead Sciences | Pharmacia & Upjohn and Gilead Sciences Receive European Recommendation for VISTIDE® gilead.com ↗ |
| 1996-08-08 | Gilead Sciences | Pharmacia & Upjohn and Gilead Sciences Announce Marketing Collaboration Outside of the U.S. for New AIDS-related Drug, VISTIDE® gilead.com ↗ |
| 1996-06-27 | Gilead Sciences | FDA Grants Marketing Clearance of Gilead's VISTIDE® for the Treatment of CMV Retinitis in Patients with AIDS gilead.com ↗ |
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 ↗ |