FDA approvals of Minoxidil solution
1979—Oral formula approved by the FDA for severe hypertension
1988—FDA approval for the 2% solution, with prescription, for hair loss in men with AGA
1992—FDA approval for the 2% solution for hair loss in women
1996—FDA approval for the 2% solution for OTC use in men and women with AGA
1997—FDA approval for the 5% solution for OTC use in men, labeled as “extra strength for men”
2006—FDA approval for the 5% foam (Rogaine®) for OTC use in men
AGA, Androgenetic alopecia; FDA, US Food and Drug Administration; OTC, over the counter.
Even though minoxidil is the only ingredient approved by the FDA for hair regrowth, it does not mean there are not other effective ingredients that cope with hair loss. Worth noting is that it takes years and costs hundreds of millions dollars to go through the rigorous clinical studies required by the FDA to obtain approval. Therefore, it is not surprising that there is good stuff out there clinically proven to be effective but not yet approved by the FDA due to the expense of the FAD approval process. Below are several clinically proven ingredients that are used in some of our products.
AzetinolTM: A proprietary extract of natural grains. Grains rich in fatty acids such as linoleic acid, oleic acid, and vitamin A are processed and extracted to obtain the effective DHT blockers retinol.
Saw Palmetto: (Serenoa repens or Sabal serrulata): A dwarf palm plant native to North America. It primarily grows along the Atlantic coast in Georgia and Florida. The active ingredients are believed to be found in the plant's brown-black berries.
It's a popular dietary supplement for conditions associated with benign prostate gland enlargement (called benign prostatic hyperplasia, or BPH).
Study shows Saw Palmetto may work similarly to finasteride. [Comparitive effectiveness of finasteride vs Serenoa repens in male androgenetic alopecia: a two-year study. Int J Immunopathol Pharmacol. 2012 Oct-Dec;25(4):1167-73.]
Ketoconazole: One of the key ingredients in a hair loss shampoo, is an effective anti-fungus reagent popular in dandruff shampoos. Some studies have shown that it increases hair density similarly to minoxidil. [Ketoconazole shampoo: effect of long-term use in androgenic alopecia. Dermatology. 1998;196(4):474-7. by Piérard-Franchimont C1, De Doncker P, Cauwenbergh G, Piérard GE.]
Emu Oil: An anti-inflammatory natural tissue nutrient, full of healthy omega oils that support heal and rejuvenate the skin, as well as deeply moisturize. A recent Boston University study found that emu oil “remarkably” increased the thickness of the scalp skin and awakened dormant hair follicles.
Retinol: studies showed that combining minoxidil and retinol works better than minoxidil alone due to the enhanced penetration of minoxidil and improved scalp condition [ Yoo HG et al, "the additive effects of minoxidil and retinol on human hair growth in vitro." Bio Pharm Bull. 2007, 20(1): 21-6].
Procyanidin Oligomers: Naturally derived ingredients that have shown to stimulate hair growth similarly to Minoxidil. Research studies have shown that procyanidin oligomers possess growth stimulation activity toward hair epithelial cells in vitro and stimulate anagen induction in hair follicles in vivo. [J Invest Dermatol. 1999 Mar;112(3):310-6. Procyanidin oligomers selectively and intensively promote proliferation of mouse hair epithelial cells in vitro and activate hair follicle growth in vivo. by Takahashi T1, Kamiya T, Hasegawa A, Yokoo Y.]
GLA, ALA, Linoleic Acid and Oleic Acid: Gamma Linolenic Acid (GLA), Alpha Linolenic Acid (ALA), linoleic and oleic acid are essential fatty acids found in plant oils, which have been demonstrated to interferes the binding of DHT to proteins in in vitro study. Additionally GLA, ALA and oleic acid also presents some anti-inflammatory properties.[J Steroid Biochem. 1988 Mar;29(3):369-70. Effect of free fatty acids on the bioavailability of plasma testosterone and dihydrotestosterone.by Mooradian AD1, Pamplona DM, Viosca SP, Korenman SG.]
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