AndroGel Future Formulations & Pipeline: What's Coming After the Standard Gel

What has FDA changed?

On Feb 28, 2025, after reviewing TRAVERSE and the required ambulatory blood pressure studies, FDA asked sponsors to add TRAVERSE results to all testosterone labels, retain the limitation of use for age-related hypogonadism, remove boxed-warning language about an increased risk of adverse cardiovascular outcomes, and add a blood pressure warning where one was missing [2]. The ambulatory studies, FDA said, confirmed a blood pressure increase with all testosterone products, class-wide [2].

In June 2026 FDA requested two further updates: removing the limitation of use stating that safety and efficacy in age-related hypogonadism have not been established, and revising safety information on prostate cancer and benign prostatic hyperplasia [1]. FDA also said TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [1]. FDA asked manufacturers to make that change, and labels checked through August 2026 still carried the old limitation, so a request is not the same as a revised label [1]. The approved indication is unchanged: low testosterone together with an associated medical condition, such as testicular failure or a pituitary or hypothalamic problem [1].

What the gel 1% label already says

The testosterone gel 1% label warns that transfer to children can cause virilization, with children and women told to avoid contact with unwashed or unclothed application sites, and says the gel is not recommended in men with uncontrolled hypertension [5]. The same label reports a mean ambulatory blood pressure rise of 1.9/1.3 mm Hg systolic/diastolic after 16 weeks in 169 evaluable patients, and 3.0/2.2 mm Hg in men already on antihypertensive treatment [5].

TRAVERSE tested testosterone gel 1.62% (AndroGel 1.62%) against placebo in men with hypogonadism and preexisting or high risk of cardiovascular disease [6][1].

What the other approved routes look like

FDA lists oral, topical gel, transdermal patch, buccal system and injection formulations [2]. A nasal metered gel, Natesto 5.5 mg per actuation, was approved on May 28, 2014 under NDA 205488 [3].

In a network meta-analysis of 29 placebo-controlled randomized trials in 3,393 men, mean hematocrit rose, compared with placebo, by 3.0% with gel, 1.4% with patch, 4.3% with oral testosterone undecanoate, 4.0% with intramuscular enanthate or cypionate and 1.6% with intramuscular undecanoate [4]. Intramuscular enanthate or cypionate produced a significantly larger rise than patches; differences between the other route pairs were not significant [4].

Does the route change anything for fertility?

The testosterone gel 1% label says exogenous androgens may lead to azoospermia [5]. Testosterone suppresses the pituitary hormones that drive sperm production (luteinizing hormone and, at larger doses, follicle stimulating hormone), and the Endocrine Society recommends against starting testosterone therapy in men planning fertility in the near term [7]. In a retrospective case series without a comparison group, 47 of 49 men (95.9%) with azoospermia or severe oligospermia on testosterone who received hCG every other day plus clomiphene, tamoxifen, anastrozole or recombinant FSH had returning sperm production or improved counts, over an average of 4.6 months [8].