FDA approvals of Minoxidil solution
1979—Oral formulation 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 FDA for hair regrowth, it does not mean there are no other effective ingredients that would 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 FDA to obtain its approval. Therefore, it is not surprising that there are good stuff out there that are clinically proven to be effective but not approved by FDA yet due to the prohibitive cost of 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. Note: AzenitolTM is a trade mark of Lipogaine.
Saw palmetto: (Serenoa repens or Sabal serrulata): it is 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 has become an accepted herbal remedy for symptoms associated with benign prostate gland enlargement (called benign prostatic hyperplasia, or BPH).
Just like finasteride was initially used for BPH and later discovered for hair regrowth, Saw plametto has the same story. Nowadays saw palmetto is widely used as an alternative DHT blocker by those who don't want to use finasteride (brand name Propecia). It is believed to prevent hair loss by blocking the conversion of testosterone into dihydrotestosterone (DHT), the same mechanism as finasteride works.
Ketoconazole: one of the key ingredients in the shampoo, is an effective anti-fungus reagent in popular dandruff shampoos. It is found to disrupt the synthesis of dihydrotestosterone (DHT), prevent DHT receptor of follicles from binding to DHT, and remove sebum deposited around follicle.
Emu Oil: An anti-inflammatory natural tissue nutrient, full of healthy omega oils that moisturize deeply, healing and rejuvenating the skin. 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. Addition of procyanidin oligomers to LipoGaine is intended to achieve better hair growth stimulation than minoxidil alone.
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 individually proven to inhibit 5-Alpha Reductase. In fact these are the most powerful inhibitors of 5-Alpha Reductase known today and not only they inhibit the Type II form of the 5-alpha reductase which other products like Propecia® inhibit, but also the Type I form of the enzyme which is present in high concentrations in the scalp, sebaceous glands, and the skin. Additionally GLA, ALA and oleic acid have potent anti-inflammatory properties.
Statements in this site have not been evaluated by the Food and Drug Administration. The products in this site are not intended to diagnose, treat, cure, or prevent any disease.