Multiple clinical trials have evaluated the pharmacokinetics, safety, and therapeutic efficacy of famciclovir across viral and autoimmune conditions, including herpes simplex, recurrent herpes labialis, genital herpes in HIV-positive individuals, and multiple sclerosis. Spanning Phase 2, combined Phase 2/3, Phase 3, and unassigned protocols, these studies were sponsored by institutions such as Novartis Pharmaceuticals, Queen Mary University of London, and Holdsworth House Medical Practice. The majority of these trials are completed, with a clinical trial currently marked as having an unknown recruitment status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05283551 | Unknown status | Multiple Sclerosis |
Queen Mary University of London |
2020-11-25 | Phase 2 |
| NCT00878072 | Completed | Herpes Labialis |
Novartis Pharmaceuticals|Novartis |
2009-03-25 | Phase 2|Phase 3 |
| NCT01154543 | Completed | HIV Positive|Herpes Simplex Genital |
Holdsworth House Medical Practice |
2008-03 | -- |
| NCT00448227 | Completed | Herpes Simplex |
Novartis |
2007-10 | Phase 2 |
| NCT00098059 | Completed | Herpes Simplex |
Novartis Pharmaceuticals|Novartis |
2005-02 | Phase 3 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).