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Valgancyclovir
Valgancyclovir is a Small molecule drug developed by University of Wisconsin, Madison. It is currently in Phase 1 development.
Valganciclovir is used to treat or prevent conditions such as Kaposi Sarcoma, CMV Viremia, and Immune Reconstitution Syndrome, particularly in patients with Human Immunodeficiency Virus. It is also used in kidney transplantation to prevent CMV infection.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Valgancyclovir |
|---|---|
| Sponsor | University of Wisconsin, Madison |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients (PHASE2)
- Impact of Valganciclovir on Severe IRIS-Kaposi Sarcoma Mortality: an Open-label, Parallel, Randomized Controlled-trial. (PHASE2)
- Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response (PHASE4)
- Combination Immunosuppressive Therapy to Prevent Kidney Transplant Rejection in Adults (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Valgancyclovir CI brief — competitive landscape report
- Valgancyclovir updates RSS · CI watch RSS
- University of Wisconsin, Madison portfolio CI
Frequently asked questions about Valgancyclovir
What is Valgancyclovir?
Who makes Valgancyclovir?
What development phase is Valgancyclovir in?
Related
- Manufacturer: University of Wisconsin, Madison — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing