FDA approves novel testosterone undecanoate capsule for hypogonadism


The FDA has approved testosterone undecanoate (Tlando), for the treatment of adult men with hypogonadism, according to Antares Pharma, the developer of the oral treatment for testosterone replacement therapy.1

According to the FDA label, the treatment is approved for either a) primary hypogonadism (congenital or acquired), defined as testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals, or b) hypogonadotropic hypogonadism (congenital or acquired), defined as gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.

“The FDA approval of Tlando brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. We have recently expanded our commercial organization to 108 sales representatives and expect to leverage our relationships with urologists and endocrinologists to drive adoption of Tlando,” Robert F. Apple, president and chief executive officer, Antares Pharma, stated in a press release.

The pivotal trial supporting approval of the oral testosterone undecanoate was Study 16-002,2 which included 95 hypogonadal males. All patients received testosterone undecanoate at 225 mg twice daily for approximately 24 days. Patients treatment doses were not titrated. The median patient age was 56 years (range 29-74), 70% were obese (BMI ≥ 30 kg/m2), 50% had a history of hypertension, and 23% had a history of type 2 diabetes. Overall, 81% of patients were White, 16% were Black, 2% were mixed race, and 1% were Asian.

The primary study end point was the percentage of patients who, on the final visit of the study, reached a 24-hour average serum testosterone concentration (Cavg0-24h) within the normal range (300-1080 ng/dL). This end point was reached with 80% (95% CI, 72-88) of patients achieving this benchmark.

Secondary end points for the study were the percentage of patients with maximum total testosterone concentration (Cmax) meeting 3 limits predetermined by the study design: less than or equal to 1.5 times the upper limit of the normal range (ULN; 1620 ng/dL), between 1.8 and 2.5 times ULN (1944 - 2700 ng/dL), and greater than 2.5 times ULN (2700 ng/dL). The results showed that the percentage of patients meeting these 3 limits were 82%, 5%, and 0%, respectively.

Regarding safety, adverse reactions occurring in >2% of patients were blood prolactin increase (6.3%), weight increase (2.1%), headache (2.1%), and musculoskeletal pain (2.1%). There was only 1 patient who had an adverse reaction (gastric ulcer hemorrhage) that resulted in study discontinuation.

The FDA label included 3 contraindications for oral testosterone undecanoate in male patients: known or suspected prostate cancer, hypersensitivity to this treatment or any of its ingredients, or hypogonadalconditions not associated with structural or genetic etiologies.


1. Antares Pharma Announces FDA Approval Of TLANDO™, an Oral Treatment for Testosterone Replacement Therapy.

2. FDA Label TLANDO (testosterone undecanoate) capsules. Accessed March. https://bit.ly/3wNbeiw

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