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Valtrex® 1000 mg
Valtrex® 1000 mg is a Small molecule drug developed by Mylan Pharmaceuticals Inc. It is currently in Phase 1 development.
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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 | Valtrex® 1000 mg |
|---|---|
| Sponsor | Mylan Pharmaceuticals Inc |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Fed Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg (PHASE1)
- Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg (PHASE1)
- Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg (PHASE1)
- Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
- A Study of Vacyless® Versus Valtrex® in Patients With Herpes Zoster (PHASE4)
- An Open-label Trial of the Effect of Valacyclovir on Plasma HIV-1 Levels Among HIV-1 Seropositive and HSV-1/2 Seronegative Persons (NA)
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:
- Valtrex® 1000 mg CI brief — competitive landscape report
- Valtrex® 1000 mg updates RSS · CI watch RSS
- Mylan Pharmaceuticals Inc portfolio CI
Frequently asked questions about Valtrex® 1000 mg
What is Valtrex® 1000 mg?
Who makes Valtrex® 1000 mg?
What development phase is Valtrex® 1000 mg in?
Related
- Manufacturer: Mylan Pharmaceuticals Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing