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Dienogest Pill
Dienogest Pill is a Small molecule drug developed by Uludag University. It is currently in Phase 1 development. Also known as: Visanne Group.
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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 | Dienogest Pill |
|---|---|
| Also known as | Visanne Group |
| Sponsor | Uludag University |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy (NA)
- "Quick-starting" of a Quadriphasic Contraceptive Pills, 1 - 3 mg Estradiol Valerate/ 2 - 3 mg Dienogest VS 20 mcg Ethinylestradiol/75 mcg Gestodene Focusing on Ovulation Inhibition (NA)
- The Progression From Dysmenorrhoea to Chronic Pelvic Pain
- Evaluation of Using Dienogest and N-Acetyl Cysteine on the Volume of Uterine Leiomyoma (PHASE2, PHASE3)
- Comparing the Safety and Efficacy in the Use of Hormonal Therapy on Endometriosis Patients After Conservative Surgery (PHASE3)
- Role of Medical Treatment in Endometriosis Patients Undergoing ICSI (NA)
- The Effect of Dienogest vs. Norethindrone Acetate Treatment in Endometriosis (NA)
- Efficacy of Dienogest Versus Oral Contraceptive Pills on Pain Associated With Endometriosis (PHASE2, 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:
- Dienogest Pill CI brief — competitive landscape report
- Dienogest Pill updates RSS · CI watch RSS
- Uludag University portfolio CI
Frequently asked questions about Dienogest Pill
What is Dienogest Pill?
Who makes Dienogest Pill?
Is Dienogest Pill also known as anything else?
What development phase is Dienogest Pill in?
Related
- Manufacturer: Uludag University — full pipeline
- Also known as: Visanne Group
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing