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Testosterone Cypionate
Testosterone cypionate is an intramuscular androgen replacement therapy indicated for male hypogonadism conditions. It has a half-life of approximately eight days with 98% plasma protein binding and hepatic metabolism. Contraindications include breast/prostate cancer, pregnancy, and serious cardiac, hepatic, or renal disease. Drug interactions with anticoagulants and insulin require dosage monitoring and adjustment.
At a glance
| Generic name | Testosterone Cypionate |
|---|---|
| Sponsor | Azurity |
| Drug class | Androgen |
| Target | Androgen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 1978 |
Approved indications
- Primary Hypogonadism
- Hypogonadotropic Hypogonadism
Common side effects
- Fatigue
- Nausea
- Pain
- Constipation
- Anemia
- Anorexia
- Vomiting
- Dysgeusia
- Creatinine increase
- Diarrhea
- Cough
- Dizziness or Lightheadedness
Drug interactions
- oral anticoagulants
- oxyphenbutazone
- insulin
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC (PHASE2)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Testosterone Replacement Therapy in Hypogonadal Patients With Prostate Cancer Under Active Surveillance (PHASE4)
- Bipolar Androgen Therapy to Restore Sensitivity to Androgen Deprivation Therapy for Patients With Metastatic Castration Resistant Prostate Cancer (PHASE1)
- Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) (PHASE2)
- Perioperative Testosterone Replacement Therapy for the Improvement of Post-Operative Outcomes in Patients With Low Testosterone (PHASE1)
- Androgen Effects on the Reproductive Neuroendocrine Axis, 2025 Version (PHASE4)
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:
- Testosterone Cypionate CI brief — competitive landscape report
- Testosterone Cypionate updates RSS · CI watch RSS
- Azurity portfolio CI