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Understanding the Timeline: When Did People Start Using Finasteride?

4 min read

Finasteride was originally approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia (BPH) under the brand name Proscar, with its use for male pattern hair loss following five years later. The story of when did people start using finasteride is one of scientific discovery and a fortunate observation during clinical trials.

Quick Summary

The timeline of finasteride's use began with an FDA approval in 1992 for enlarged prostate, followed by a separate approval in 1997 for male pattern hair loss after an observed side effect during early trials sparked further research.

Key Points

  • Initial Use (1992): The first approved use of finasteride was in 1992 for treating benign prostatic hyperplasia (BPH) under the brand name Proscar (5mg).

  • Hair Loss Discovery: During clinical trials for BPH, researchers observed the unexpected side effect of hair regrowth, which led to the development of a hair loss treatment.

  • Hair Loss Approval (1997): A separate, lower-dose (1mg) version of finasteride, branded as Propecia, was approved by the FDA in 1997 specifically for male pattern hair loss.

  • Generic Availability: Following the patent expirations for Proscar in 2006 and Propecia in 2013, generic versions of finasteride became widely available, increasing accessibility.

  • Mechanism of Action: Finasteride works by inhibiting the 5-alpha reductase enzyme, which reduces levels of dihydrotestosterone (DHT) responsible for both BPH and hair follicle miniaturization.

  • Long-Term Effectiveness: Studies, including multi-year clinical trials, have confirmed finasteride's long-term effectiveness in slowing hair loss and promoting regrowth with continued daily use.

In This Article

The Scientific Discovery Behind Finasteride

Before its official medical use, the origins of finasteride can be traced back to a fascinating medical observation in the Dominican Republic in 1974. Researchers, including Julianne Imperato-McGinley, studied a unique genetic condition in male children caused by a deficiency in the enzyme 5-alpha reductase. This deficiency meant these children had very low levels of dihydrotestosterone (DHT), a potent male hormone. When these children reached adulthood, they had significantly smaller prostate glands and never developed male pattern baldness.

These findings provided a critical insight into the role of DHT in prostate enlargement and hair loss. The pharmaceutical company Merck, inspired by this research, set out to develop a drug that could mimic this natural genetic trait by inhibiting the 5-alpha reductase enzyme. This work led to the development of finasteride, with the goal of creating a treatment for both benign prostatic hyperplasia (BPH) and hair loss.

The First Approval: Finasteride for BPH (Proscar)

In 1992, the first form of finasteride received its official approval from the U.S. Food and Drug Administration (FDA). This was the 5-mg dose, marketed under the brand name Proscar, for the treatment of benign prostatic hyperplasia (BPH), or an enlarged prostate. The development prioritized the treatment of this more serious medical condition over the cosmetic concern of hair loss. The drug works by blocking the enzyme that converts testosterone into DHT, thereby shrinking the prostate and improving urinary symptoms.

During these initial clinical trials, a serendipitous observation was made: men taking the medication for BPH experienced an unexpected side effect—hair regrowth. This finding confirmed the scientific theory that DHT was a primary driver of male pattern hair loss and paved the way for the drug's second application.

The Second Approval: Finasteride for Hair Loss (Propecia)

Following the promising side effects seen during the Proscar trials, Merck pursued a separate application for finasteride as a hair loss treatment. This led to the FDA's approval of a lower-dose, 1-mg version of finasteride in December 1997, which was marketed under the brand name Propecia.

Propecia became the first oral medication in history to effectively treat male pattern baldness, offering a new hope for many men facing progressive hair loss. It effectively lowers DHT levels in the scalp, which in turn helps to stop the miniaturization of hair follicles and promote new hair growth. Clinical studies demonstrated significant hair growth and a slowing of hair loss progression in a large percentage of men using the medication daily.

The Rise of Generic Finasteride and Other Developments

After Merck's patents on finasteride expired, the market saw the introduction of generic versions of both Proscar and Propecia, making the medication more widely accessible and affordable. The expiration of the Proscar patent occurred in June 2006, while the patent for the use of finasteride for hair loss expired in November 2013.

History of Finasteride Key Dates

  • 1974: Study published detailing findings on boys with 5-alpha reductase deficiency.
  • 1984: Finasteride molecule is patented.
  • 1992: FDA approves the 5-mg dose (Proscar) for benign prostatic hyperplasia (BPH).
  • 1997: FDA approves the 1-mg dose (Propecia) for male pattern hair loss.
  • June 2006: Merck's patent for BPH treatment expires, allowing for generic 5-mg finasteride.
  • November 2013: Merck's patent for hair loss treatment expires, allowing for generic 1-mg finasteride.
  • 2023: Finasteride becomes one of the most commonly prescribed medications in the US.

How Finasteride Targets Hair Loss

Finasteride's effectiveness stems from its targeted biological action. Here's a breakdown of the key steps:

  • Enzyme Inhibition: Finasteride functions as a 5-alpha reductase inhibitor.
  • DHT Reduction: It blocks the specific Type II 5-alpha reductase enzyme that converts testosterone into dihydrotestosterone (DHT).
  • Follicle Protection: By lowering DHT levels in the scalp, finasteride helps to prevent the miniaturization of hair follicles, a key factor in male pattern baldness.
  • Hair Cycle Reversal: The reduction in DHT allows hair follicles to return to a normal growth cycle (anagen phase), leading to thicker, stronger hair over time.

Comparison of Proscar vs. Propecia

While both brand names refer to the same active ingredient, finasteride, their intended use and dosage differ significantly. This distinction is crucial for patient safety and efficacy.

Feature Proscar Propecia
Indication Benign Prostatic Hyperplasia (BPH) Male Pattern Hair Loss (Androgenetic Alopecia)
Dosage 5 mg 1 mg
First FDA Approval 1992 1997
Typical User Men with enlarged prostate issues, often over 50. Men experiencing male pattern hair loss.
Primary Mechanism Shrinks enlarged prostate by reducing DHT. Prevents further hair loss and promotes regrowth by reducing scalp DHT.
Side Effect Likelihood May be higher due to the higher dosage. Lower incidence of side effects compared to 5mg dose.
Onset of Effects May take 6 months or longer to see symptom improvement. Visible hair results usually begin within 3-6 months.

Conclusion

The journey of finasteride from a serendipitous side effect discovery to a mainstream treatment for both BPH and hair loss illustrates the unpredictable path of pharmacological development. When did people start using finasteride? The answer is twofold: first in 1992 for prostate health and later in 1997 for addressing hair loss. The foundational scientific observations in the 1970s laid the groundwork for a medication that would impact millions of lives, offering a novel solution to conditions linked to the male hormone DHT. Continued research and the availability of generic forms have solidified its place in modern medicine, although understanding the history and specific indications remains key to its proper use.

For more detailed information on finasteride's development, clinical trials, and safety profile, the National Library of Medicine (NIH) provides authoritative resources, such as the StatPearls article on finasteride.

Frequently Asked Questions

Finasteride was first approved by the FDA on June 19, 1992, under the brand name Proscar, for the treatment of benign prostatic hyperplasia (BPH).

People started using finasteride for hair loss following its specific FDA approval for male pattern hair loss on December 19, 1997, under the brand name Propecia.

Proscar (5mg finasteride) is for benign prostatic hyperplasia, while Propecia (1mg finasteride) is for male pattern hair loss. They are the same active ingredient but in different dosages for different conditions.

No, finasteride does not work immediately. It can take three to six months to see initial results, with more noticeable improvements often appearing around the 9-12 month mark, because it takes time for the hair growth cycle to reset.

The hair growth effect was a side effect observed in men participating in clinical trials for the treatment of BPH using finasteride. This observation led to further research and a separate FDA application for hair loss.

Yes, generic finasteride became available after the expiration of Merck's patents for BPH in 2006 and for hair loss in 2013.

Finasteride is not recommended for women, especially those who are or may become pregnant, due to the risk of birth defects in a male fetus. Clinical trials in postmenopausal women with hair loss showed no significant benefit.

Finasteride is typically used as a long-term treatment. If medication is discontinued, the hair loss process usually resumes over the following months.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.