Wellness
October 23, 2024

What Is Pregnenolone? Uses, Evidence and FDA Status

Pregnenolone is a hormone your body makes from cholesterol. It is the starting material for other hormones, including progesterone, testosterone, estrogen and cortisol. It is sold as a supplement and promoted for energy, memory and “hormone balance”, but the U.S. Anti-Doping Agency says there is no clear scientific evidence that it works for these purposes, and no pregnenolone product is FDA-approved.

This guide explains what pregnenolone is, what is known and not known about taking it, and its regulatory status.

What is pregnenolone?

Pregnenolone is produced naturally, mainly by the adrenal glands. Because the body uses it to build other steroid hormones, it is often called a precursor or pro-hormone.

That role is the basis of the marketing. The idea is that taking more of the starting material will raise the hormones made from it.

What is pregnenolone promoted for?

The U.S. Anti-Doping Agency (USADA) summarises it this way: there has long been interest in pregnenolone “as an anti-aging compound, for hormone replacement, and to treat a myriad of medical conditions.” It is advertised as boosting other hormones and making people feel more energetic and younger.

USADA’s conclusion is direct: “There is no clear scientific evidence that pregnenolone is effective for this purpose.”

You will also see claims about memory, mood, joint pain, skin and immunity. We have not found an authoritative medical body that supports pregnenolone for any of these, so this guide does not repeat them as benefits.

Is pregnenolone FDA-approved?

No. USADA states that pregnenolone “is considered an unapproved new drug and therefore cannot be legally compounded or included in dietary supplements,” and notes that the FDA has sent warning letters to companies marketing it.

One example is a 2018 FDA warning letter to a supplement company. Its pregnenolone product was promoted for depression, arthritis and other conditions, and the FDA told the company that the product was not generally recognized as safe and effective for those uses and was an unapproved new drug.

The practical meaning is that pregnenolone products have not been reviewed by the FDA for safety, effectiveness or quality.

Is pregnenolone safe?

There is not enough reliable information to say. Without FDA review, there is no approved dose and no required safety labelling.

The FDA’s general advice on supplements applies. It says many supplements “contain ingredients that can have strong effects in the body,” and that some can interact with medications or interfere with lab tests. USADA considers any supplement that claims to deliver or “boost” hormones to be especially risky.

The FDA advises talking with a health care professional, such as your doctor or pharmacist, before buying or taking any supplement. That matters more if you take hormone therapy or other medicines.

Pregnenolone and hormone therapy

Pregnenolone is sometimes included in compounded hormone preparations. The FDA, the Endocrine Society and ACOG all recommend FDA-approved hormone therapy over compounded products. Our guide to bioidentical hormone therapy explains why.

If your concern is a symptom such as tiredness, low mood or low sex drive, the more useful step is finding the cause. These guides may help:

Frequently asked questions

What does it do in the body?

It is the starting material the body uses to make other steroid hormones, including progesterone, testosterone, estrogen and cortisol.

Does taking it raise other hormones?

That is the marketing claim. USADA says there is no clear scientific evidence that it is effective for this.

Is it banned in sport?

USADA says it is not on the World Anti-Doping Agency’s Prohibited List, but advises athletes to be cautious with any product claiming to contain it.

Next step

If you have symptoms you think are hormonal, book a consultation to discuss assessment and the treatments that have evidence behind them. You can also read about hormonal imbalances.