Legal status · United States
Is Degarelix legal in the United States?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
Yes. Degarelix is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile.
- People given it
- 610
- Found nothing
- 0
Legal category
FDA-approved, prescription only
NDA 022201, approved 24 December 2008, made by Ferring, sold as Firmagon. It is approved for advanced prostate cancer and nothing else. Given only as a shot under the skin.
Reviewed Sep 2026. This is a legal category, not legal advice.
A "research use only" label on a vial does not make it legal to use on people.
Degarelix in the United States at a glance
| Legal category | FDA-approved, prescription only |
|---|---|
| Note | NDA 022201, approved 24 December 2008, made by Ferring, sold as Firmagon. It is approved for advanced prostate cancer and nothing else. Given only as a shot under the skin. |
| FDA approval status | FDA-approved on 24 December 2008 under NDA 022201, sold as Firmagon, to treat advanced prostate cancer. No boxed warning. Not approved for any use beyond that, including prostate cancer that has not spread, any use in women, or any use in healthy adults. |
| Studies in people | 3 of 3 sources on the profile |
| Reviewed | Sep 2026 |
The legal category and note come from the Degarelix profile. We checked them against U.S. Food and Drug Administration (FDA) listings on the reviewed date.
What this means
- 01
FDA has approved Degarelix for at least one use named on its label. So a proper pharmacy-grade product exists in the United States, and pharmacies hand it out on prescription.
- 02
Approval covers only the uses named on the label. Any other use is a prescriber's call. The approval itself does not cover it.
- 03
Unlicensed vials sold online, including those labeled "research use only", are not the approved product. The approval does not cover them.
What Degarelix is
A hormone blocker approved in 2008 for advanced prostate cancer. In its main study of 610 men, testosterone was down to castration level by day 3 in about 96 percent on degarelix, and in none on the older drug, leuprolide. Over 12 months it held testosterone down just as well. 40 percent had reactions where the shot went in, against under 1 percent on leuprolide. The study built to test whether it is easier on the heart was stopped early and found no difference.
Degarelix is a man-made chain of ten building blocks. Five of them are mirror-image forms.
How it works: It blocks the GnRH receptor in the pituitary gland directly. That stops the hormones that drive the testes right away, so testosterone falls within days with no first surge.
Approval history: FDA-approved on 24 December 2008 under NDA 022201, sold as Firmagon, to treat advanced prostate cancer. No boxed warning. Not approved for any use beyond that, including prostate cancer that has not spread, any use in women, or any use in healthy adults.
How FDA treats this kind of product
Approves prescription drugs, each for a named use. It also acts against unapproved products, including peptides sold online. Compounding pharmacies, which mix drugs to order, may make some compounds with a prescription. That only applies when the FDA puts the compound in a category of bulk ingredients it allows.
The legal category above is how The Longevity Archive reads U.S. Food and Drug Administration listings for Degarelix on the reviewed date. It is not a legal opinion. Rules change. Bringing a compound into the country, prescribing it and owning it can each be treated differently. Check with the agency before you act on anything here.
Degarelix in sport and the military
Whether Degarelix is banned in sport is set by the World Anti-Doping Code and by military rules, not by its legal status in the United States. Before you compete or get tested, look up Degarelix by name on the Prohibited List, or look up a named product in Global DRO. Under the World Anti-Doping Code, category S0 bans, at all times, any drug-like substance that meets two tests. No other section of the List covers it. And no government health regulator anywhere has a current approval for it as a treatment in people. Many substances that are approved somewhere are banned by name in another section. So approval does not mean a substance is allowed in sport.
- WADA Prohibited List
- Global DRO (check a named product)
- USADA (US athletes)
- Operation Supplement Safety (US service members)
The rules you compete or serve under decide this, not this page.
Degarelix in other countries
Frequently asked questions
Is Degarelix legal in the United States?
Yes. Degarelix is an approved medicine in the United States. Its legal category is "FDA-approved, prescription only". The approval covers the use on its label. It is given out on prescription, not sold over the counter. Products labeled "research use only" are not covered by that approval, and that label does not make them legal to use in people. On the evidence, 2 completed human trials are cited on its profile. Note: NDA 022201, approved 24 December 2008, made by Ferring, sold as Firmagon. It is approved for advanced prostate cancer and nothing else. Given only as a shot under the skin.
Can I buy Degarelix in the United States?
Only with a prescription. In the United States, Degarelix has the legal category "FDA-approved, prescription only". Pharmacies hand it out with a prescription, for the use it is approved for. Buying it from unlicensed sellers online, or as a "research chemical", is outside that system. You get none of the protection the regulator gives. Note: NDA 022201, approved 24 December 2008, made by Ferring, sold as Firmagon. It is approved for advanced prostate cancer and nothing else. Given only as a shot under the skin.
Is Degarelix FDA approved?
Yes. FDA status: FDA-approved on 24 December 2008 under NDA 022201, sold as Firmagon, to treat advanced prostate cancer. No boxed warning. Not approved for any use beyond that, including prostate cancer that has not spread, any use in women, or any use in healthy adults.. Current US legal category: "FDA-approved, prescription only". On the evidence, 2 completed human trials are cited on its profile.
Related compounds in the United States
Full research profile
How Degarelix works, the studies we cite, FDA status and the full legal summary are all on its compound profile.
Degarelix profileThis page is general information about the legal status of Degarelix in the United States, current as of Sep 2026. It is not legal advice. Legal status changes. For your own situation, check with U.S. Food and Drug Administration or ask a lawyer. Educational use only. This database summarizes published research and is not medical advice. Where a dose appears it is a record of what a trial or clinic ran, or what people describe doing, with its source attached. Nothing here is a recommendation for personal use. Sellers named on the price pages are ranked by certificate tier, then price, and any affiliate income is disclosed there. Naming a seller is not a recommendation to buy or use anything.