Testosterone Enanthate Compassionate Use and Expanded Access: A 2026 Guide

Is testosterone enanthate available through compassionate use?

Testosterone enanthate is not an investigational drug. Generic intramuscular testosterone enanthate is an approved, marketed prescription product in the United States, and its label identifies it as a Schedule III controlled substance [1]. Because it is approved, the access step for its labeled uses is a prescription rather than an investigational-drug application.

What testosterone enanthate is actually approved for

The generic enanthate label covers replacement therapy in conditions caused by a deficiency or absence of endogenous testosterone. That means primary hypogonadism from testicular failure (cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome or orchidectomy) and hypogonadotropic hypogonadism from gonadotropin or LHRH deficiency, or from pituitary or hypothalamic injury due to tumor, trauma or radiation [1]. The label also covers brief treatment to stimulate puberty in carefully selected males with clearly delayed puberty [1].

The same label states that safety and efficacy in men with age-related hypogonadism have not been established [1]. FDA says none of the approved testosterone products is approved for men with low testosterone who lack an associated medical condition [2]. In June 2026 FDA asked for label updates that remove that limitation of use and revise prostate cancer and benign prostatic hyperplasia safety information [2]. The Hikma enanthate label checked (effective May 2026) still carried the older limitation text [1].

What the label says about diagnosis and dosing

The prescribing information says hypogonadism should be confirmed with morning serum testosterone measurements on at least two separate days, with both results below the normal range [1]. For male hypogonadism the label gives a suggested dose of 50 to 400 mg every 2 to 4 weeks, injected slowly and deeply into the gluteal muscle. It says total doses above 400 mg per month are generally not required and injections more often than every two weeks are rarely indicated [1].

The label lists men with breast cancer or known or suspected prostate cancer, and women who are or may become pregnant, as contraindications [1]. The Endocrine Society guideline recommends against starting testosterone therapy in men who plan fertility in the near term [3].

What the label and FDA flag during treatment

Intramuscular testosterone enanthate has no boxed warning [1]. Blood pressure is the class-wide issue: FDA's February 2025 labeling action stated that ambulatory blood pressure monitoring studies confirmed a blood pressure increase with all testosterone products, and it required a blood pressure warning in products that lacked one [4]. The Hikma enanthate label says testosterone can increase blood pressure and that blood pressure should be monitored periodically [1]. That label also still contains the older cardiovascular paragraph: long-term safety trials have not been conducted, studies have been inconclusive for major adverse cardiovascular events, and some studies, but not all, have reported an increased risk [1].

Hematocrit is the other issue. In a network meta-analysis of 29 placebo-controlled trials covering 3,393 men, intramuscular testosterone enanthate or cypionate raised mean hematocrit by 4.0% versus placebo (95% CI 2.9 to 5.1) [5]. The enanthate label lists polycythemia and venous thromboembolism among adverse reactions [1]. The largest cardiovascular outcome trial, TRAVERSE, tested a 1.62% testosterone gel in 5,246 men, not an injectable. Major adverse cardiovascular events occurred in 7.0% of men on testosterone versus 7.3% on placebo [6].