Last reviewed 2026-04-20 · How we verify

Tlando (UNDECANOATE)

Tlando works by increasing testosterone levels in the body.

Tlando, an undecanoate formulation by Tolmar, is currently marketed for the treatment of primary hypogonadism. Its key strength lies in its mechanism of action, which effectively increases testosterone levels, addressing a critical need in patients with this condition. The primary risk to Tlando's market position is the expiration of its key composition patent in 2028, which could lead to increased competition from generics.

At a glance

Mechanism of action

Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis and scrotum; the development of male hair distribution, such as facial, pubic, chest and axillary hair; laryngeal enlargement, vocal cord thickening, alterations in body musculature and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies. Primary hypogonadism is caused by defects of the gonads, such as Klinefelter's Syndrome or Leydig cell aplasia, whereas secondary hypogonadism is the failure of the hypothalamus (or pituitary) to produce sufficient gonadotropins (FSH, LH).

Approved indications

• Primary Hypogonadism
• Hypogonadotropic Hypogonadism

Common side effects

• hypertension
• hematocrit increased
• upper respiratory tract infection
• blood prolactin increased
• weight increased
• headache
• musculoskeletal pain

Drug interactions

• Insulin
• Oral Anticoagulants
• Corticosteroids
• Drugs that May Also Increase Blood Pressure

Key clinical trials

• Body Composition Assessment in Transgender Population.
• Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism (PHASE2)
• Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone? (PHASE2,PHASE3)
• Phase 1 Study of Dimethandrolone Undecanoate in Healthy Men (PHASE1)
• Injectable DMAU for Male Contraception in Healthy Male Volunteers (CCN015) (PHASE1)
• Study of Spermatogenesis Suppression With DMAU Alone or With LNG Versus Placebo Alone in Normal Men (PHASE2)
• Cardiovascular Health of Transgender Individuals During the Gender-affirming Pathway
• Safety and Efficacy of Oral Testosterone Undecanoate Followed by Enzalutamide as Therapy for Men With Metastatic Castrate Resistant 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.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tlando CI brief — competitive landscape report
• Tlando updates RSS · CI watch RSS
• Tolmar portfolio CI