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Valganciclovir Tablets
Valganciclovir Tablets is a Small molecule drug developed by Cecilia Soderberg-Naucler. It is currently in Phase 2 development. Also known as: Valcyte, ValGANcilovir, Valganciclovir 450 mg, J05AB14.
Valganciclovir Tablets are small molecule medications used to treat conditions such as cytomegalovirus infections and CMV disease, particularly in patients who have undergone kidney transplantation. They are also used to study pharmacokinetics and therapeutic equivalency in various clinical trials.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Valganciclovir Tablets |
|---|---|
| Also known as | Valcyte, ValGANcilovir, Valganciclovir 450 mg, J05AB14, Valganciclovir oral |
| Sponsor | Cecilia Soderberg-Naucler |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes (PHASE2, PHASE3)
- A Study of Maribavir in Chinese Adults With Cytomegalovirus (CMV) Infections (PHASE3)
- Combination Letermovir and Standard of Care Antiviral for Enhanced Antiviral Response in Cytomegalovirus Infection in Lung Transplant Recipients (PHASE4)
- Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections (PHASE3)
- A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients (PHASE2)
- A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
- Empirical Treatment Against Cytomegalovirus and Tuberculosis in HIV-infected Infants With Severe Pneumonia (PHASE2, PHASE3)
- EBV Lytic Reactivation Therapy Combined With PD-1 Antibody in Recurrent/Metastatic Nasopharyngeal Carcinoma (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:
- Valganciclovir Tablets CI brief — competitive landscape report
- Valganciclovir Tablets updates RSS · CI watch RSS
- Cecilia Soderberg-Naucler portfolio CI
Frequently asked questions about Valganciclovir Tablets
What is Valganciclovir Tablets?
Who makes Valganciclovir Tablets?
Is Valganciclovir Tablets also known as anything else?
What development phase is Valganciclovir Tablets in?
Related
- Manufacturer: Cecilia Soderberg-Naucler — full pipeline
- Also known as: Valcyte, ValGANcilovir, Valganciclovir 450 mg, J05AB14, Valganciclovir oral
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing