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Natazia (DIENOGEST)
Natazia works by binding to the progesterone receptor in the body, mimicking the effects of the natural hormone progesterone.
Natazia (DIENOGEST) is a small molecule progestin that targets the progesterone receptor. It is used for contraception and treating dysmenorrhea, and was FDA approved in 2010. Natazia has a half-life of 11.0 hours and bioavailability of 94%. The commercial status of Natazia is patented, as it is owned by Mochida Pharmaceutical Co., Ltd. Key safety considerations include its mechanism of action as a progestin, which may affect menstrual bleeding and increase the risk of blood clots.
At a glance
| Generic name | DIENOGEST |
|---|---|
| Sponsor | Mochida Pharmaceutical Co., Ltd. |
| Drug class | Progestin |
| Target | Progesterone receptor |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2010 |
Mechanism of action
Think of it like a key fitting into a lock. Natazia is a key that fits into the progesterone receptor, which is a lock in the body's cells. This helps to regulate the menstrual cycle and prevent pregnancy.
Approved indications
- Contraception
- Dysmenorrhea
Boxed warnings
- WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke. [See Contraindications ( 4 ).] WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Natazia. ( 4 ) • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
Common side effects
- Intermenstrual bleeding
- Pharyngeal hypoaesthesia
- Coeliac disease
- Cerebellar stroke
Key clinical trials
- MRI-Based Prediction of Dienogest Response in Endometriosis
- Ovarian Blockade During Fertility Preservation in Patients With Endometriosis
- Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis
- Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy (NA)
- Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis (PHASE3)
- "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 Role of Thread Embedding Acupuncture for Pain and Quality of Life in Endometriosis Patients (NA)
- Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Natazia CI brief — competitive landscape report
- Natazia updates RSS · CI watch RSS
- Mochida Pharmaceutical Co., Ltd. portfolio CI