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Valette
Valette is a Small molecule drug developed by Bayer. It is currently in Phase 3 development.
Valette is a medication that combines Dienogest and Ethinyl Estradiol, used for conditions such as oral contraceptive and acne vulgaris. It is a test product in clinical trials, compared to a reference product of the same composition.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Bayer is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Valette |
|---|---|
| Sponsor | Bayer |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Synthetic vs Natural Estrogen in Combined Oral Contraception (PHASE4)
- Study on Safety and Efficacy of an Oral Contraceptive in Treating Acne Papulopustulosa (PHASE3)
- Bioavailability Study With Oral Single Dose Administration of Ethinylestradiol and Dienogest (NA)
- Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product (PHASE1)
- Valette (Combined Oral Contraceptive SH T04769G and SH D00659AF) Low Ovulation Inhibition (PHASE2)
- Bleeding Pattern Study (PHASE3)
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:
- Valette CI brief — competitive landscape report
- Valette updates RSS · CI watch RSS
- Bayer portfolio CI
Frequently asked questions about Valette
What is Valette?
Who makes Valette?
What development phase is Valette in?
Related
- Manufacturer: Bayer — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing