MedPath

Finasteride

Generic Name
Finasteride
Brand Names
Entadfi, Propecia, Proscar
Drug Type
Small Molecule
Chemical Formula
C23H36N2O2
CAS Number
98319-26-7
Unique Ingredient Identifier
57GNO57U7G
Background

Finasteride is a synthetic 4-azasteroid compound and specific inhibitor of steroid Type II 5α-reductase, which is an intracellular enzyme that converts the androgen testosterone into 5α-dihydrotestosterone (DHT). It works in a similar fashion as dutasteride, which is another 5-alpha-reductase inhibitor, by exerting antiandrogenic effects. Finasteride is an orally active drug that was first approved by the FDA in 1992 for the treatment of benign prostatic hyperplasia to improve symptoms and reduce the risk for acute urinary retention or the need for surgical procedures. In 1998, it was approved by the FDA to treat male pattern hair loss. Finasteride is commonly marketed under the brand names Propecia and Proscar to be used aloneo or in combination with doxazosin, an alpha-blocker.

Both benign prostatic hyperplasia and androgenic alopecia are androgen-dependent disorders that are characterized by in situ high levels of DHT. In the treatment of benign prostate hyperplasia, alpha-blockers such as tamsulosin and terazosin are also used. Compared to alpha-blockers that focus on providing the rapid relief of symptoms, 5α-reductase inhibitors aim to target the underlying disease by blocking the effects of the primary androgen involved in benign prostate hyperplasia and androgenic alopecia, thus reducing the risk for secondary complications while providing symptom control.

Indication

Finasteride is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention, and reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. A combination product with tadalafil is also used for the symptomatic treatment of BPH for up to 26 weeks.

Finasteride is also indicated for the treatment of male pattern hair loss (androgenetic alopecia, hereditary alopecia, or common male baldness) in male patients.

Associated Conditions
Androgenetic Alopecia (AGA), Benign Prostatic Hyperplasia (BPH), Idiopathic Hirsutism, Symptomatic benign prostatic hyperplasia (BPH)

EU Regulator Confirms Suicidal Thoughts as Rare Side Effect of Hair Loss Drug Finasteride

• The European Medicines Agency has confirmed suicidal thoughts as a rare side effect of finasteride, a medication commonly used to treat male pattern hair loss in men aged 18-41. • Following a review of 313 reports of suicidal ideation, the EMA will now require patient warning cards in packages of 1mg finasteride tablets, though the regulator maintains that benefits outweigh risks. • Similar warnings will be added to dutasteride, another medication used for prostate enlargement, as a precautionary measure despite limited evidence linking it to suicidal thoughts.

FDA Warns of Serious Side Effects from Unapproved Topical Finasteride Hair Loss Treatments

• The FDA has issued a warning about unapproved topical formulations of finasteride (generic Propecia) sold through telehealth companies, citing 32 reports of serious adverse events including suicidal thoughts and erectile dysfunction. • Unlike FDA-approved oral finasteride (Propecia and Proscar), these compounded topical versions lack comprehensive safety data and regulatory scrutiny, yet are widely promoted on social media with minimal risk disclosure. • Medical experts have raised concerns that telehealth companies may prioritize prescription volume over patient safety, with some patients reporting they weren't adequately informed about potential severe side effects.

Androgenetic Alopecia Pipeline Shows Promise with Over 100 Therapies in Development

• DelveInsight's latest report reveals a robust pipeline for androgenetic alopecia with 80+ companies developing 100+ therapeutic candidates across various clinical stages. • Key emerging treatments include KX-826 from Kintor Pharma and Clascoterone from Cassiopea, which could significantly expand options beyond the current FDA-approved minoxidil and finasteride. • Recent clinical trial results from companies like Veradermics, Chong Kun Dang, and Pelage Pharmaceuticals demonstrate increasing R&D investment in addressing this common condition affecting up to 50% of both men and women.

FDA Removes Ozempic and Wegovy from Shortage List, Sparking Legal Challenge from Compounding Groups

• The FDA has officially removed Novo Nordisk's semaglutide products, Ozempic and Wegovy, from its drug shortage list after being listed since 2022, signaling improved supply availability. • Compounding groups have filed a lawsuit challenging the FDA's decision, arguing it was made without proper stakeholder consultation and despite ongoing supply challenges acknowledged by Novo Nordisk. • The legal dispute highlights broader tensions between pharmaceutical manufacturers and compounding facilities over access to semaglutide for treating type 2 diabetes, obesity, and cardiovascular disease.

Novel Non-Hormonal Hair Loss Treatment VDPHL01 Enters Phase 2/3 Clinical Trials

• Veradermics has launched a nationwide Phase 2/3 clinical trial for VDPHL01, a promising non-hormonal oral treatment for androgenetic alopecia, backed by a $75 million funding round. • The investigational drug shows potential for hair growth within two months of treatment, offering an alternative to existing options that often come with hormonal side effects or application challenges. • The multi-center trial aims to enroll 480 male participants across 44 US sites, with preliminary Phase 2 data expected in the coming months.

Veru's Enobosarm Shows Promise in Phase IIb Trial for Enhanced Weight Management

• Phase IIb QUALITY trial demonstrates significant improvements in lean mass retention and fat loss when combining enobosarm with semaglutide, compared to placebo. • The study reports 80.6% of treated patients maintained stair climb power near baseline, indicating enhanced functional benefits particularly relevant for older populations. • Higher 6mg dose of enobosarm showed superior improvements in fat loss metrics, prompting plans for Phase III program development.

FDA Approves Gemtesa (Vibegron) for Overactive Bladder in Men with BPH

• The FDA has approved Gemtesa (vibegron) for men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). • Gemtesa is the first and only beta-3 adrenergic receptor agonist approved for OAB in men being treated for BPH, addressing a significant unmet need. • Approval was based on a Phase 3 trial demonstrating significant reductions in micturition and urgency episodes compared to placebo. • Common adverse reactions in the trial included hypertension and urinary tract infections, with a similar rate of serious adverse events to placebo.

Cutia Therapeutics' CU-40102 Demonstrates Efficacy in Phase III Trial for Androgenetic Alopecia

• Cutia Therapeutics' CU-40102 topical finasteride spray significantly improved hair count in Chinese male patients with androgenetic alopecia in a Phase III trial. • The trial met its primary endpoint, showing statistically significant improvement in total hair count compared to placebo after 24 weeks (p < 0.05). • CU-30101, another Cutia product, proved as effective as Pliaglis® in providing localized analgesia for surface dermatologic operations. • The New Drug Application for CU-40102 has been accepted by China's National Medical Products Administration in January 2024.

EMA Reviews Finasteride and Dutasteride Hair Loss Drugs Over Suicidal Ideation Concerns

• The European Medicines Agency (EMA) is reviewing finasteride and dutasteride, drugs used for hair loss and benign prostatic hyperplasia, due to concerns about potential suicidal thoughts. • The review was initiated following a request from the French medicines agency, which suggested a possible link between the drugs and suicidal ideation based on new safety assessments. • Finasteride is the active ingredient in Organon's Propecia and Proscar, while dutasteride is found in GSK's Avodart, with psychiatric side effects already a known risk. • The EMA will assess whether marketing authorizations for these drugs should be maintained, changed, or withdrawn, while Organon has stated it stands by the safety of its finasteride products.
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