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NOMEGESTROL
NOMEGESTROL is a nomegestrol drug. It is currently in Phase 2 development.
Nomegestrol is a progestin receptor modulator that works by binding to and activating the progesterone receptor, influencing hormone-sensitive processes.
Nomegestrol is a small molecule drug belonging to the nomegestrol class, originally developed by an unknown entity and currently owned by an unknown entity. Its target and exact mechanism of action are unknown, and it has not been approved by the FDA for any indications. The commercial status of nomegestrol is unclear, with unknown generic manufacturers and patent status. Further research is needed to determine its safety profile and efficacy. As a result, nomegestrol is not a commercially available treatment option.
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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 | NOMEGESTROL |
|---|---|
| Drug class | nomegestrol |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Mechanism of action
Imagine your body's hormones as a lock and key system. Nomegestrol is a key that fits into a specific lock, the progesterone receptor, and turns it on or off to affect various bodily functions. This can help regulate menstrual cycles, pregnancy, and other hormone-sensitive processes.
Approved indications
Common side effects
Key clinical trials
- Contraceptive Efficacy and Safety of NOMAC-E2 Combined Oral Contraceptive (PHASE3)
- The Progression From Dysmenorrhoea to Chronic Pelvic Pain
- Study of the Contraceptive Efficacy and Safety of a NOMAC-E2 Combined Oral Contraceptive (COC)(P06448) (PHASE3)
- A Dose-Finding Study to Evaluate Ovarian Function and Vaginal Bleeding in Next Generation Rings (P06109/MK-8175A/MK-8342B-012) (PHASE2)
- A Study to Evaluate the Effect of Contraceptive Vaginal Rings on Primary Dysmenorrhea (P08257/MK-8175A/MK-8342B-057) (PHASE2)
- The Use of Drospirenone/Estetrol, Nomegestrol Acetate/Estradiol and Ethinylestradiol/Dienogest in Random Start Rapid Endometrial Preparation (PHASE4)
- The Use of Nomegestrol Acetate/Estradiol in Random Start Rapid Endometrial Preparation (PHASE4)
- Efficacy and Safety of Oral NOMAC-E2 in Indian Women (P07057/MK-8175A-017) (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:
- NOMEGESTROL CI brief — competitive landscape report
- NOMEGESTROL updates RSS · CI watch RSS
Frequently asked questions about NOMEGESTROL
What is NOMEGESTROL?
How does NOMEGESTROL work?
What drug class is NOMEGESTROL in?
What development phase is NOMEGESTROL in?
Related
- Drug class: All nomegestrol drugs
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing