Last reviewed · How we verify
Vogelxo
At a glance
| Generic name | Vogelxo |
|---|---|
| Sponsor | Upsher-Smith Laboratories |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: SECONDARY EXPOSURE TO TESTOSTERONE Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions (5.2) and Adverse Reactions (6.2) ] . Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ] . Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and
Common side effects
- Clinically notable increase in hematocrit (≥58%)
- Clinically notable increase in hemoglobin (≥19 g/dL)
- Acne
- Sensitive nipples
- Appetite increased
- Prothrombin time prolonged
- Blood creatinine increased
- Activated partial thromboplastin time prolonged
Serious adverse events
- Myocardial infarction
- Stroke
- Venous thromboembolism
- Depression with suicidal ideation
- Hypertension
- Mood swings
- Urinary tract infection
- Secondary exposure to testosterone in children - virilization
Key clinical trials
- Body Composition Assessment in Transgender Population.
- Novel Approaches for Minimizing Drug-Induced QT Interval Lengthening (PHASE4)
- Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PHASE2)
- Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC (PHASE2)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (PHASE2, PHASE3)
- 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)
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:
- Vogelxo CI brief — competitive landscape report
- Vogelxo updates RSS · CI watch RSS
- Upsher-Smith Laboratories portfolio CI