A new wave of cholesterol treatment drugs is not likely to even gain approval due mostly to new heart health regulations in the U.S. that favor more potent options, Reuters reported.

The new drugs were billed to have huge sales potential as well as revolutionize the way cholesterol is treated. Pfizer Inc., Amgen Inc. and a partnership of Regeneron Inc. and French drug maker Sanofi SA are rushing their new drugs onto the market to try and be ahead of the regulation changes.

The drugs are in mid-stage trials and feature an injectable method. Thus far in their trials, they have sliced levels of "bad" LDL cholesterol by 60 percent greater than the reductions of statins. They are so effective because they block a certain protein responsible for maintaining the presence of LDL in the bloodstream, called PCSK9.

"I read the new guidelines as a negative for any drugs that aren't statins, including PCSK9 inhibitors," said Jon LeCroy, an analyst with MKM Partners.

About 25 percent of Americans aged 45 and older take statin drugs such as Lipitor and Zocor to treat their high cholesterol. New guidelines set out by the American Heart Association and the American College of Cardiology could leave many Americans with no other options. The new guidelines could keep the newer drugs from ever seeing the market.

"It's really about your global risk," Donald Lloyd-Jones, chair of the Department of Preventive Medicine at Northwestern University, told the Washington Post. "There were a number of people at substantial risk who, under the old paradigm, were not being captured."

Lloyd-Jones is one of 20 experts on the committee that wrote the new guidelines that encourage doctors to consider age, weight, blood pressure and various other factors like smoking and pre-existing illness. Even if a person has a moderate risk of a heart attack or stroke, the new guidelines would require the doctor to prescribe a statin, despite LDL scores.

Heart disease is the number-one killer of men and women in America, accounting for about one in every four deaths. According to the Centers for Disease Control and Prevention, about 600,000 die from heart disease every year and 700,000 experience a heart attack or stroke.

The new guidelines may be preventing potentially revolutionary drugs from seeing the market, but they also hope to help people lower their medical expenses used for heart related emergencies.