Whether FDA approves Dutasteride for androgenic alopecia AGA

Dutasteride is FDA-approved, but is not intended to treat androgenic alopecia. The only oral drug approved by the FDA for the treatment of AGA is Finasteride.

FDA approved Dutasteride

The FDA approved Dutasteride in 2001 for the treatment of benign prostatic hypertrophy (BPH). Therefore, Dutasteride is an FDA-approved drug. Finasteride has a similar story, having been FDA-approved first for BPH and later for androgenic alopecia.

The fundamental reason Dutasteride is used to treat BPH is that it acts on the 5-alpha-reductase, reducing the conversion of testosterone into DHT.DHT acts as a more potent androgen that accumulates in the prostate gland and thus leads to an enlarged prostate. When 5-alpha-reductase converts testosterone into DHT in the scalp, it causes androgenic alopecia. Therefore, Dutasteride is equally effective in treating AGA.

Why are so many people using Dutasteride to treat AGA?

Dutasteride is not approved by the FDA to treat AGA, but Dutasteride is widely used to treat androgenic alopecia.

First, while Dutasteride is not FDA-approved for androgenic alopecia, it is FDA-approved for BHP. When Dutasteride is used to treat androgenic alopecia, the dosage is the same as that used to treat BPH, and it can even work in a smaller dose, while its safety is well established.

Second, while Dutasteride is not approved by the FDA, it was approved in South Korea and then Japan for the treatment of androgenic alopecia. After the patent expired in 2015, a large number of generic versions of Dutasteride also appeared in the United States and proved its effect in actual use by people.

In summary, although Dutasteride is not approved by the FDA for the treatment of AGA, it does not affect the purchase and use of it by people with androgenic alopecia.

In the end, the actual use of Dutasteride determines its popularity. Multiple studies have found that Dutasteride induces hair regrowth faster and to a greater extent than the highest approved dose of Finasteride. This is because Dutasteride acts on all three subtypes of 5α-reductase, reducing the user’s systemic DHT levels by more than 99%, while Finasteride reduces circulating DHT levels by 70%. For those AGA patients who are sensitive to DHT, an additional reduction of about 30% in circulating DHT levels means a lot.