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Cytadren (AMINOGLUTETHIMIDE)
Cytadren (Aminoglutethimide) is a small molecule adrenal steroid synthesis inhibitor developed by Novartis, targeting aromatase to treat secondary malignant neoplasm of female breast. It was FDA approved in 1980 and remains a Novartis-owned product. Cytadren is off-patent, with no active Orange Book patents. As an inhibitor of adrenal steroid synthesis, it works by blocking the conversion of cholesterol to pregnenolone, a precursor to cortisol and other hormones. This mechanism ultimately reduces estrogen production, which can help slow the growth of hormone-sensitive breast cancer.
At a glance
| Generic name | AMINOGLUTETHIMIDE |
|---|---|
| Sponsor | Novartis |
| Drug class | Adrenal Steroid Synthesis Inhibitor |
| Target | Aromatase |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1980 |
Approved indications
- Secondary malignant neoplasm of female breast
Common side effects
Drug interactions
- tamoxifen
Key clinical trials
- Randomized Study Comparing Tamoxifen vs. Tamoxifen + Aminoglutethimide in Postmenopausal Receptor-positive Patients (PHASE3)
- A Phase II Trial of Early Medical Adrenalectomy for "D0.5" Prostate Cancer (PHASE2)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cytadren CI brief — competitive landscape report
- Cytadren updates RSS · CI watch RSS
- Novartis portfolio CI