Litfulo (ritlecitinib)

To treat severely patchy hair loss Drug Trials Snapshot

FDA Approval: 6/23/2023

Research Synopsis

  • Recent studies highlight that Ritlecitinib (Litfulo), a selective JAK3/TEC inhibitor, shows promising efficacy in treating moderate to severe alopecia areata, demonstrating significant hair regrowth compared to placebo in clinical trials.
  • A phase 2b-3 trial involving 718 participants revealed favorable outcomes with a majority experiencing meaningful improvement in their condition.
  • The medication was also well-tolerated, with most adverse effects being mild and manageable.
  • Furthermore, Ritlecitinib is being investigated for its effectiveness in treating other autoimmune conditions, such as vitiligo and rheumatoid arthritis.
  • Research indicates that JAK inhibitors like Ritlecitinib are emerging as first-line treatments for alopecia areata, and the FDA approved the first JAK inhibitor specifically for this condition in 2022.
  • Clinical trials and studies have shown that ritlecitinib significantly improves hair regrowth and has a good safety profile, although concerns about long-term efficacy and safety persist.
  • Recent systematic reviews underline that while adverse events are generally mild, there are instances of serious side effects, necessitating ongoing monitoring of patients on JAK inhibitors.
  • Overall, the body of research supports Ritlecitinib as a viable therapeutic option for alopecia areata while advocating for additional studies to confirm its long-term outcomes and safety in diverse populations.
  • The burgeoning interest in JAK inhibitors marks a pivotal shift in alopecia areata management, with Ritlecitinib being at the forefront of this advancement.

Related articles

Research articles about Litfulo (ritlecitinib)

Litfulo (ritlecitinib)

Discovery of a novel and highly selective JAK3 inhibitor as a potent hair growth promoter.

London, UK

2 hours ago

1 Received

  • Scientists have found a new drug called MJ04 that could help with hair loss by blocking a specific part of a pathway in the body.
  • This drug has shown great results in tests on mice, making their hair grow back quicker when applied directly to the skin.
  • MJ04 is safe to use and works well, making it a good option for future studies in humans to help people with hair loss.

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A phase 2a randomized, placebo-controlled study to evaluate the efficacy and safety of the oral Janus kinase inhibitors ritlecitinib and brepocitinib in alopecia areata: 24-week results.

London, UK

2 hours ago

1 Received

  • Alopecia areata (AA) is a type of hair loss caused by the immune system, and this study aimed to test the effectiveness of two drugs, ritlecitinib and brepocitinib, in patients with significant scalp hair loss.
  • In a 24-week trial, both drugs showed a significant improvement in hair regrowth compared to a placebo, with brepocitinib being more effective than ritlecitinib.
  • The treatments were generally well tolerated, although there was a case of a serious side effect (rhabdomyolysis) in the brepocitinib group.

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Ritlecitinib: an investigational drug for the treatment of moderate to severe alopecia areata.

London, UK

2 hours ago

1 Received

  • Alopecia areata (AA) is an autoimmune condition causing hair loss that can range from one patch to complete body hair loss, with no guaranteed treatments available.
  • Ritlecitinib, a new oral JAK3-selective inhibitor, is being studied for its effectiveness and safety in treating AA, based on data from a 24-week clinical trial.
  • If approved, ritlecitinib may offer a new, safer treatment option for severe cases of AA and could also be explored for other hair loss disorders due to its unique action on hair growth and inflammation.

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JAK3 inhibitors for the treatment of inflammatory and autoimmune diseases: a patent review (2016-present).

London, UK

2 hours ago

1 Received

  • Eight Janus kinase (JAK) inhibitors have been approved for autoimmune and myeloproliferative diseases, with JAK3 being notable for its specific expression in hematopoietic tissues and potential for targeting autoimmune disorders.
  • The study provides a review of patent literature on JAK inhibitors published since 2016 and summarizes recent clinical findings on selective JAK3 inhibitors.
  • While no selective JAK3 inhibitors are currently approved, recent studies, especially on Pfizer's ritlecitinib, highlight their promising potential for treating inflammatory and autoimmune diseases.

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Ritlecitinib and brepocitinib demonstrate significant improvement in scalp alopecia areata biomarkers.

London, UK

2 hours ago

1 Received

  • Janus kinase (JAK) inhibitors, specifically ritlecitinib and brepocitinib, are being studied for treating alopecia areata (AA) with promising results from early research.
  • In a phase 2a clinical trial, biopsy samples from 46 patients showed significant improvements in scalp biomarkers after 24 weeks, correlating with hair regrowth measured by the Severity of Alopecia Tool (SALT) score.
  • While brepocitinib showed better results at week 12, ritlecitinib outperformed it by week 24, suggesting the need for larger and longer-term trials to confirm these findings.

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Characterizing the relationships between patient-reported outcomes and clinician assessments of alopecia areata in a phase 2a randomized trial of ritlecitinib and brepocitinib.

London, UK

2 hours ago

1 Received

  • The ALLEGRO trial studied the safety and effectiveness of two medications, ritlecitinib and brepocitinib, in adults with alopecia areata, focusing on the connection between clinician assessments and patient-reported outcomes.
  • Both treatment groups showed significant improvements in patient-reported symptoms (AASIS scores) and clinician-assessed hair loss (SALT scores) after 24 weeks compared to placebo.
  • The trial found medium-to-large positive correlations between patient-reported outcomes and clinician assessments, indicating that improvements in symptoms reported by patients align with observed reductions in hair loss severity.

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Evaluating the Therapeutic Potential of Ritlecitinib for the Treatment of Alopecia Areata.

London, UK

2 hours ago

1 Received

  • - Alopecia areata (AA) is an autoimmune disorder causing patchy hair loss in about 147 million people worldwide, with no FDA-approved treatments specifically for AA and limited effective options for severe cases.
  • - Ritlecitinib, a selective JAK3/TEC kinase inhibitor, shows promise by blocking immune signals linked to hair loss and is also being studied for use in other autoimmune conditions like vitiligo and rheumatoid arthritis.
  • - Clinical trials indicate that taking Ritlecitinib (50 mg or 30 mg daily for 24 weeks) can significantly promote hair regrowth in AA patients, with many achieving minimal hair loss after six months, though more research is needed for long-term outcomes.

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Maintenance, withdrawal, and re-treatment with ritlecitinib and brepocitinib in patients with alopecia areata in a single-blind extension of a phase 2a randomized clinical trial.

London, UK

2 hours ago

1 Received

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The efficacy and safety of JAK inhibitors for alopecia areata: A systematic review and meta-analysis of prospective studies.

London, UK

2 hours ago

1 Received

  • A systematic review and meta-analysis evaluated the effectiveness and safety of Janus Kinase (JAK) inhibitors for treating alopecia areata (AA), using 14 prospective studies with a total of 1845 patients.
  • Results showed that oral JAK inhibitors were significantly more effective than controls, while topical options did not differ significantly.
  • The study highlighted a high recurrence rate of 54% after treatment withdrawal and suggested continuous treatment to maintain efficacy, noting that most adverse events reported were mild and manageable.

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Safety and Efficacy of Ritlecitinib and Brepocitinib in Alopecia Areata: Results from the Crossover Open-Label Extension of the ALLEGRO Phase 2a Trial.

London, UK

2 hours ago

1 Received

  • The ALLEGRO phase 2a trial investigated the safety and effectiveness of two drugs, ritlecitinib and brepocitinib, for treating alopecia areata over a 24-week period, followed by an additional extension phase for patients who did not respond adequately.
  • A total of 18 patients switched from ritlecitinib to brepocitinib, while 5 switched the other way, with no new safety concerns reported post-crossover.
  • An exploratory analysis indicated that some patients switched to brepocitinib showed significant improvement in hair loss severity, suggesting potential benefits for those not responding to ritlecitinib, though firm conclusions are limited due to the small sample size.

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Emerging drugs for the treatment of alopecia areata.

London, UK

2 hours ago

1 Received

  • Recently, oral baricitinib became the first drug approved specifically for the treatment of AA, marking a significant step forward.
  • Despite new treatments, many patients still experience high recurrence rates, and AA should be viewed as a systemic condition that impacts quality of life rather than just an aesthetic issue.

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Efficacy and safety of oral ritlecitinib for the treatment of active nonsegmental vitiligo: A randomized phase 2b clinical trial.

London, UK

2 hours ago

1 Received

  • Vitiligo is a chronic autoimmune condition that leads to skin depigmentation, and this study aimed to assess the effectiveness and safety of ritlecitinib, a JAK3/TEC inhibitor, in treating active nonsegmental vitiligo in a phase 2b trial.
  • The trial involved 364 patients who received various doses of ritlecitinib or a placebo over 24 weeks, with improvements in vitiligo severity significantly noted in those taking ritlecitinib compared to placebo.
  • Ultimately, the study concluded that ritlecitinib was both effective and well-tolerated for 48 weeks, although it excluded patients with stable vitiligo.

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Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics.

London, UK

2 hours ago

1 Received

  • Ritlecitinib is a drug that inhibits specific kinases (JAK3 and TEC) and is being studied for its pharmacokinetics and safety in people with liver and kidney issues.
  • Due to the pandemic, one study on healthy participants was paused, but researchers used data from another study with participants having liver impairment to derive new insights using statistical and simulation models.
  • The results showed that people with renal impairment likely won’t need any dose adjustment for ritlecitinib, and the studies confirmed that the drug is generally safe and well-tolerated.

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Adverse events in patients treated with Jak-inhibitors for alopecia areata: A systematic review.

London, UK

2 hours ago

1 Received

  • Recent studies highlight the effectiveness of JAK-inhibitors (JAK-I) for treating alopecia areata (AA), but their safety in patients is still under-researched.
  • A systematic review conducted in August 2022 analyzed data from 28 studies involving 1,719 patients to evaluate the adverse events (AEs) linked to six different JAK-I medications.
  • Most AEs were mild, with a low withdrawal rate due to side effects; however, laboratory abnormalities and increased infection rates were noted, along with isolated severe cases, but no fatalities were reported.

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JAK inhibitors in dermatology: the road travelled and path ahead, a narrative review.

London, UK

2 hours ago

1 Received

  • * Recent literature indicates that while there is growing interest in JAK inhibitors for treating inflammatory and autoimmune skin diseases, only a few conditions have undergone thorough clinical studies.
  • * The effectiveness of JAK inhibitors in dermatology is well-supported for some conditions but remains largely anecdotal for others, highlighting the need for more robust research in this area.

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Systematic review of newer agents for the management of alopecia areata in adults: Janus kinase inhibitors, biologics and phosphodiesterase-4 inhibitors.

London, UK

2 hours ago

1 Received

  • Management of moderate-to-severe alopecia areata (AA) is challenging due to few safe long-term treatment options available, but newer therapies show promise for hair regrowth with fewer side effects.
  • This article reviews newer treatment agents, specifically Janus kinase (JAK) inhibitors, biologics, and phosphodiesterase-4 (PDE-4) inhibitors, by analyzing data from 12 randomized controlled trials that used the Severity of Alopecia Tool score.
  • Current findings indicate that oral JAK inhibitors, particularly baricitinib, are effective for significant hair regrowth and have received FDA approval, whereas PDE-4 inhibitors and biologics show limited success, prompting further studies to evaluate their long-term effectiveness.

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Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial.

London, UK

2 hours ago

1 Received

  • Alopecia areata causes non-scarring hair loss on the scalp and body, and this study explored the effectiveness and safety of ritlecitinib, an oral medication that inhibits certain kinases, in treating this condition.* -
  • The research was a randomized, double-blind trial across 118 sites in 18 countries, enrolling patients aged 12 and older with significant scalp hair loss, who were assigned to receive either ritlecitinib or a placebo for 24 weeks.* -
  • A total of 718 patients participated, with a majority being female (62%) and White (68%), while 104 patients discontinued treatment during the trial due to various reasons, including adverse events.*

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Safety of Janus Kinase inhibitors in Patients with Alopecia Areata: A Systematic Review.

London, UK

2 hours ago

1 Received

  • Janus kinase (JAK) inhibitors show promise as a treatment for alopecia areata, but concerns regarding their safety arise due to differences between this patient group and those with rheumatoid arthritis from whom safety data are largely drawn.* -
  • A systematic review analyzed data from 36 studies to identify the safety profile of various JAK inhibitors, highlighting the frequency of adverse events such as hypercholesterolemia, headache, and acne.* -
  • Headache and acne were the most common side effects noted, with varying odds ratios for upper respiratory infections among the different JAK inhibitors assessed.*

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The Evolving Story of JAK Inhibitors for Treating Alopecia Areata: A Review of Current Progress and Future Directions.

London, UK

2 hours ago

1 Received

  • Oral Janus kinase (JAK) inhibitors are now considered first-line treatments for advanced alopecia areata and are more effective than topical options.
  • The FDA approved baricitinib in 2022, marking a significant development in alopecia areata treatment, with more JAK inhibitors under study and potential future approvals.
  • Clinical trial data suggests that JAK inhibitors have a good safety profile, but long-term safety and efficacy data for these medications are still needed.

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