What Is Ritlecitinib?
Ritlecitinib is an FDA-approved medication for Alopecia Areata. It is an oral drug provided as capsules. Clinical trials for ritlecitinib began on September 10, 2021, and the latest trial is expected to conclude on November 14, 2025.
Beyond its approved use, ritlecitinib is currently being investigated for several other conditions. These include other forms of alopecia areata, such as severe alopecia areata, and various skin conditions like active nonsegmental vitiligo, stable nonsegmental vitiligo, and chronic spontaneous urticaria (CSU). CSU is characterized by hives and itching lasting over six weeks. Ritlecitinib is also being explored for its potential in treating CTCL (Cutaneous T-cell Lymphoma) and Type 1 Diabetes Mellitus. A total of 25 trials involving 5,618 participants have explored ritlecitinib, with 8 trials currently recruiting new participants. Pfizer is the primary sponsor, leading 19 trials of this medication.
Uses and Conditions Under Study
Ritlecitinib is being investigated for a range of conditions, primarily focusing on autoimmune and inflammatory disorders.
- Hair Loss Conditions: Ritlecitinib is extensively studied for Alopecia Areata, a chronic autoimmune disease causing non-scarring hair loss on the scalp, face, and body. This condition affects people of all ages and genders. Ritlecitinib is being evaluated for its safety and effectiveness in treating both general alopecia areata and severe alopecia areata, with a total of 9 trials.
- Vitiligo: The drug is also under investigation for active nonsegmental vitiligo and stable nonsegmental vitiligo. Vitiligo is a chronic skin disorder characterized by distinct pale white patches due to loss of skin pigment. Studies aim to assess how safe and effective ritlecitinib is for participants with this condition, with a total of 4 trials exploring its use.
- Chronic Spontaneous Urticaria (CSU): Ritlecitinib is being researched as a potential treatment for CSU, which involves hives and itching that persist for over six weeks. 2 trials are underway to determine the safety and efficacy of ritlecitinib for this condition.
- Other Conditions: Additionally, ritlecitinib is being studied for its potential in treating CTCL (Cutaneous T-cell Lymphoma) and Type 1 Diabetes Mellitus. Each of these conditions is being explored in 1 trial.
Beyond specific treatment indications, ritlecitinib has also been studied in 6 trials involving healthy volunteers or participants. These studies typically assess the drug's safety, how it is absorbed, distributed, metabolized, and excreted by the body, and its general tolerability.
Dosing
Ritlecitinib is administered orally as capsules. Clinical trials have investigated various strengths and dosing regimens for this medication.
The medication is typically taken as an oral dose once daily (QD). Doses studied in trials include 20 mg, 50 mg, and 100 mg capsules. For example, one study involved a 100 mg oral dose taken once daily for 12 weeks. Other study designs have incorporated a loading dose phase, where participants receive ritlecitinib for 8 weeks, followed by a maintenance phase, also for 8 weeks.
The capsules are centrally provided by the sponsor in high-density polyethylene (HDPE) bottles. While specific dose-condition links are not detailed for all investigational uses, the 50 mg and 100 mg strengths appear frequently in trial designs, particularly for conditions like Alopecia Areata and Chronic Spontaneous Urticaria. The exact dosage and duration of treatment would be determined by a healthcare provider based on the specific condition being treated and individual patient needs.
Side Effects
Specific types of adverse events were not detailed in the provided clinical trial data, but the number of participants who experienced any treatment-emergent adverse events (TEAEs) or laboratory abnormalities was reported.
In NCT05040295, a study comparing different Ritlecitinib formulations in healthy adults, **2 participants** taking the adult capsule, **1 participant** taking pediatric capsules, and **1 participant** taking spray congealed beads experienced treatment-emergent adverse events. A small number of participants (between 1 and 2) also experienced laboratory abnormalities across the entire study population.
A drug interaction study (NCT05097716) in healthy adults reported that **2 participants** taking Ritlecitinib alone and **3 participants** taking Ritlecitinib with tolbutamide experienced treatment-emergent adverse events.
In a target occupancy study (NCT05128058) involving healthy adults, **2 participants** on 200 mg Ritlecitinib and **3 participants** on 50 mg Ritlecitinib experienced treatment-emergent adverse events. Additionally, a small number of participants (1 or
Currently Recruiting Trials
Several clinical trials are actively recruiting participants to further understand ritlecitinib, a study medicine being investigated for various conditions. These studies aim to evaluate the safety and effectiveness of ritlecitinib in different patient populations. One study, NCT07226531, is a real-world study sponsored by Pfizer, focusing on the utilization and effectiveness of ritlecitinib in adults with severe alopecia areata (AA) in the US. AA is a chronic autoimmune disease causing hair loss, and this study plans to enroll 300 participants. Another Pfizer-sponsored study, NCT06531109, also characterizes clinical outcomes for AA patients treated with ritlecitinib, targeting 850 participants. Additionally, a real-world evidence study (NCT06573593) from Zhejiang University is comparing the efficacy and safety of various JAK inhibitors, including ritlecitinib, in AA patients, with an enrollment goal of 150 individuals. For children with severe alopecia areata, two Phase 3 studies are underway. NCT07029711 is learning about ritlecitinib in children aged 6 to 12 years with at least 50% scalp hair loss, aiming for 225 participants. A long-term Phase 3 study, NCT07029828, is also investigating ritlecitinib's safety and effects in children who have previously completed another study for severe AA, with a target of 140 participants. Ritlecitinib is also being explored for other skin conditions. A Phase 2 study (NCT07228390) is assessing its safety and effects in 240 adults with moderate or severe hidradenitis suppurativa (HS), a condition causing painful red skin lumps. Another Phase 2 study, NCT07219615, is recruiting 200 adults to learn about ritlecitinib for chronic spontaneous urticaria (CSU) that has not responded to antihistamines. Finally, the Icahn School of Medicine at Mount Sinai is sponsoring a Phase 2 study (NCT06373458) with 30 participants to investigate ritlecitinib in patients with keloids or those undergoing keloidectomy.Where to Participate
Clinical trials for ritlecitinib are widely accessible across the United States, with a broad geographic reach to accommodate diverse participants. There are currently 93 study sites located in 74 cities across 31 states. The top cities with multiple recruiting sites include:- Albuquerque, New Mexico (6 sites)
- Indianapolis, Indiana (5 sites)
- Omaha, Nebraska (5 sites)
- Tampa, Florida (4 sites)
- Miami, Florida (4 sites)
- Tamarac, Florida (3 sites)
- Marriottsville, Maryland (3 sites)
- Santa Ana, California (3 sites)
- New York, New York (3 sites)
- Waterford, Michigan (3 sites)