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Desogestrel-Reference product
Desogestrel-Reference product is a Small molecule drug developed by Bio-innova Co., Ltd. It is currently in Phase 1 development.
Desogestrel is a small molecule that acts as a progesterone receptor agonist, classified as an agonist. A bioequivalence study of Desogestrel Tablets (0.075 mg) relative to an originator product was conducted to compare the Test product and Reference product in healthy subjects.
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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 | Desogestrel-Reference product |
|---|---|
| Sponsor | Bio-innova Co., Ltd |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Desogestrel Tablets (0.075 mg) Relative to Originator Desogestrel Tablets (0.075 mg) (PHASE1)
- Bioavailability of Desogestrel 0.075 mg Tablets With Regards to Reference Product (PHASE1)
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:
- Desogestrel-Reference product CI brief — competitive landscape report
- Desogestrel-Reference product updates RSS · CI watch RSS
- Bio-innova Co., Ltd portfolio CI
Frequently asked questions about Desogestrel-Reference product
What is Desogestrel-Reference product?
Who makes Desogestrel-Reference product?
What development phase is Desogestrel-Reference product in?
Related
- Manufacturer: Bio-innova Co., Ltd — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing