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Testim
Testim, marketed by Endo Pharmaceuticals, is a testosterone replacement therapy with a key composition patent expiring in 2028. The drug's market position is bolstered by its established presence and ongoing revenue generation. However, the primary risk lies in the potential increase in competition following the patent expiry in 2028.
At a glance
| Generic name | Testim |
|---|---|
| Also known as | Testosterone gel, testosteron, Testim® is the brand name for testosterone gel. |
| Sponsor | Endo Pharmaceuticals |
| 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 ( 5.1 ) 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 ( 5.1 )]. Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage
Common side effects
- Application site reaction
- Increased hematocrit
- Increased hemoglobin
- Hypertension
Serious adverse events
- Depression with suicidal ideation
- Mood swings
- Urinary tract infection
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:
- Testim CI brief — competitive landscape report
- Testim updates RSS · CI watch RSS
- Endo Pharmaceuticals portfolio CI