Litfulo (ritlecitinib) / Pfizer - LARVOL DELTA

Properties of FDA-approved small molecule protein kinase inhibitors: a 2025 update. (PubMed, Pharmacol Res) - "Seven drugs (abrocitinib, baricitinib, deucravacitinib, deuruxolitinib, ritlecitinib, tofacitinib, upadacitinib) are prescribed for the management of inflammatory diseases (atopic dermatitis, rheumatoid arthritis, psoriasis, alopecia areata, and ulcerative colitis)...The following four drugs received FDA approval in 2024 - deuruxolitinib (alopecia areata), ensartinib and lazertinib (non-small cell lung cancer), and tovorafenib (pediatric glioma) while mirdametinib was approved in 2025 for the treatment of type I neurofibromatosis (von Recklinghausen disease). Apart from netarsudil, temsirolimus, and trilaciclib, the approved protein kinase blockers are orally bioavailable. This article summarizes the physicochemical properties of all 85 FDA-approved small molecule protein kinase inhibitors including the molecular weight, number of hydrogen bond donors/acceptors, ligand efficiency, lipophilic efficiency, polar surface area, and solubility. A total of 39 of the 85..."

FDA event • Journal • Review • Alopecia • Atopic Dermatitis • Brain Cancer • Chronic Myeloid Leukemia • CNS Tumor • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Glioma • Hematological Malignancies • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Leukemia • Lung Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Oncology • Pediatrics • Psoriasis • Psoriatic Arthritis • Rheumatoid Arthritis • Rheumatology • Solid Tumor • Ulcerative Colitis • MAP2K1

Pralsetinib induces opportunistic infection in RET fusion-positive NSCLC patients via inhibition of IL-2 production by blocking Jak3/Stat5 activation (AACR 2025) - "Additionally, to investigate the direct correlation between Jak3 and IL-2 release, JT cells were treated with ritlecitinib, a Jak3-selective inhibitor, for ~2 weeks. Pralsetinib, not Selpercatinib, inhibits additional IL-2 production by blocking Jak3/Stat5 activation triggered by IL-2 released during early T cell activation. Consequently, Jak3 inhibition by pralsetinib suppresses IL-2 release by inhibiting the activation of transcription factors for IL-2, such as JunB/c-Jun and Stat5, thereby inducing opportunistic infections, including invasive pulmonary aspergillosis (IPA), cytomegalovirus (CMV) pneumonia, CMV viremia, and pneumocystis pneumonia."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • IL2 • JAK3 • JUN • JUNB • RET • STAT5 • STAT5AWqe

The Relative Efficacy and Safety of Monotherapies for Alopecia Areata: A Network Meta-Analysis Study. (PubMed, J Cosmet Dermatol) - "We produced high-quality evidence on the comparative effectiveness of monotherapies for AA with various regimens of 8 JAKIs, including the FDA-approved ones. Our findings can improve clinicians' decision-making and update guidelines for medical practice."

Clinical • Journal • Retrospective data • Review • Alopecia • Immunology

Dermatologists show promising results using combination therapy for vitiligo patients (Medical Xpress) - P2b | N=366 | NCT03715829 | Sponsor: Pfizer | "In a 24-week extension of a phase 2b clinical trial, the Mount Sinai researchers found that patients receiving ritlecitinib with nbUVB phototherapy experienced greater improvements in vitiligo severity compared to those receiving ritlecitinib alone. Notably, the combination led to a mean 69.6% improvement in facial repigmentation, compared to 55.1% with ritlecitinib alone. Total body repigmentation also improved more significantly with the combination therapy."

P2b data • Vitiligo

Efficacy and Safety of Zimlovisertib, Ritlecitinib and Tofacitinib, Alone and in Combination, in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate. (PubMed, Arthritis Rheumatol) - "Zimlovisertib+tofacitinib was more effective than tofacitinib for the primary endpoint, while the efficacy of zimlovisertib+ritlecitinib did not achieve statistical significance vs tofacitinib. All treatments were well tolerated."

Journal • Hepatocellular Cancer • Immunology • Infectious Disease • Inflammatory Arthritis • Novel Coronavirus Disease • Oncology • Rheumatoid Arthritis • Rheumatology • Solid Tumor • CRP • IRAK4

Real-world Effectiveness and Safety of Janus Kinase Inhibitors in Alopecia Areata: A Retrospective Cohort Study of 72 Patients. (PubMed, Acta Derm Venereol) - "This retrospective, single-centre cohort study evaluated the real-world effectiveness and safety of JAKi (abrocitinib, baricitinib, ritlecitinib, upadacitinib, and tofacitinib) in 72 patients treated between December 2017 and February 2024. The findings indicate that JAKi are effective and safe for AA treatment in real-world settings. Further prospective studies are necessary to optimize treatment guidelines."

Journal • Real-world evidence • Retrospective data • Alopecia • Immunology • Renal Disease • Sickle Cell Disease

Real-world study on the efficacy and safety of Ritlecitinib in Chinese patients with severe alopecia areata: A single-center, prospective, observational study (ChiCTR) - P4 | N=160 | Not yet recruiting | Sponsor: Xiangya Hospital, Central South University; Xiangya Hospital, Central South University

New P4 trial • Alopecia • Dermatology • Immunology

Ritlecitinib for Cicatricial Alopecia (clinicaltrials.gov) - P2 | N=50 | Completed | Sponsor: Emma Guttman | Active, not recruiting ➔ Completed

Trial completion • Alopecia • Dermatology • Immunology

Safety and Efficacy of Ritlecitinib for the Treatment of Patients with Alopecia Areata: A Systematic Review and Meta-Analysis of Controlled Trials. (PubMed, J Clin Med) - "This higher rate of serious events in the placebo arm could be explained by the placebo effect, although these differences were statistically non-significant. These findings suggest that Ritlecitinib holds promise as an effective treatment for AA with an acceptable safety profile, warranting further investigation in larger cohorts and long-term studies."

Journal • Retrospective data • Review • Acne Vulgaris • Alopecia • Immunology • Infectious Disease • Pain

Real-world efficacy and safety of ritlecitinib in alopecia areata: A single-centre experience. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Real-world evidence • Alopecia • Immunology

A Cost Per Responder Analysis of Ritlecitinib and Baricitinib: Assessing the Impact of Clinical Efficacy and Dosing Variability on Overall Treatment Costs of Severe Alopecia Areata (AA) (ISPOR 2025) - "Ritlecitinib is more cost-effective per responder than baricitinib at Weeks 24 and 52. These findings support reimbursement or formulary inclusion of ritlecitinib for the treatment of AA. Given the modelling approach, results may be sensitive to response assessment timepoints and up-titration timing, which may vary in clinical practice."

Clinical • HEOR • Treatment costs • Alopecia • Immunology

Oral ritlecitinib for the treatment of refractory vitiligo: a retrospective study. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Retrospective data • Dermatology • Immunology • Vitiligo

ALLEGRO-100: A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Pfizer

New P3 trial • Alopecia • Dermatology • Immunology

Litfulo Capsules Special Investigation (clinicaltrials.gov) - P=N/A | N=191 | Active, not recruiting | Sponsor: Pfizer | N=39 ➔ 191

Enrollment change • Alopecia • Dermatology • Immunology

Efficacy and safety of ritlecitinib in Asian patients with alopecia areata: A subgroup analysis of the ALLEGRO phase 2b/3 trial. (PubMed, J Dermatol) - "Ritlecitinib demonstrated clinical efficacy and acceptable safety over 48 weeks in Asian patients ≥12 years with AA and ≥50% hair loss. Results for the Asian subpopulation were consistent with the overall population in the ALLEGRO-2b/3 study."

Journal • P2/3 data • P2b data • Alopecia • Cardiovascular • Dermatology • Immunology • Infectious Disease • Oncology • Respiratory Diseases • Urticaria • JAK3

Network meta-analysis (NMA) of FDA-approved JAK inhibitors for alopecia areata (AA) with at least 50% hair loss per SALT score. (AAD 2025) - "Background: For adult patients with severe AA, 3 Janus kinase (JAK) inhibitors are currently approved in the United States: baricitinib (2 mg and 4 mg regimens), ritlecitinib (50 mg regimen), and deuruxolitinib (8 mg regimen). Deuruxolitinib was associated with numerically or statistically greater efficacy when compared to other approved systemic JAK inhibitors for severe AA."

Retrospective data • Alopecia • Immunology

Treatment Patterns of Patients with Alopecia Areata Treated with FDA-approved JAK inhibitors (AAD 2025) - "High discontinuation rates of baricitinib suggest a need for additional therapeutic options for patients with AA. Further study of the reasons for baricitinib discontinuation and the pattern of ritlecitinib treatment is warranted."

Clinical • Alopecia • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Rational and efficacy of janus kinase inhibitor switching for alopecia areata (AAD 2025) - " We identified a retrospective cohort of 67 AA patients who received at least two oral JAKIs (tofacitinib, ruxolitinib, baricitinib, upadicitinib, ritlecitinib) between December 2014 and March 2024. AA patients mainly changed JAKI agents related to inadequate treatment response or medication access. The most common switch (from tofacitinib to baricitinib) was not associated with a differential response."

Clinical • Alopecia • Immunology

Switching between Janus kinase inhibitors for treatment of alopecia areata (AAD 2025) - "Partial responses were observed in patients switched from deuruxolitinib to baricitinib and then ritlecitinib (n=1), and from ruxolitinib to tofacitinib and then baricitinib (n=1). Switching JAKis may benefit patients with severe alopecia areata who fail initial treatment. Whether this is due to dose effect or JAK specificity requires further study."

Alopecia • Immunology

Systemic Janus kinase inhibitors in the treatment of severe alopecia areata in pediatric patients (AAD 2025) - "Treatment options for pediatric patients are limited, with ritlecitinib being the sole FDA-approved therapy for those12 and above (3)... Of the 8 eligible patients included in this review, 5 (62.5%) received oral baricitinib and 3 (37.5%) received oral tofacitinib... Oral JAKis are an effective and safe treatment for pediatric patients with severe AA. Larger prospective studies are needed and are underway to confirm these findings."

Clinical • Acne Vulgaris • Alopecia • Immunology • Pediatrics

Patient Preferences for the Treatment of Alopecia Areata (AAD 2025) - "This study found that, with regard to JAK-inhibitor treatment options in AA, given similar safety profiles, patients prefer higher efficacy and shorter time to initial hair regrowth, regardless of daily or twice daily dosing."

Clinical • Alopecia • Immunology

Alopecia Universalis: Never Give Up? (PubMed, J Drugs Dermatol) - "The authors aim to report this case to highlight the success of prolonged JAKi therapy for patients with severe refractory alopecia areata and the success of JAKi therapy after failure of a prior JAKi. Dermatologists should consider longer courses of these medications and switching within the class for patients who experience poor response with initial agents. J Drugs Dermatol. 2025;24(3):316-318. doi:10.36849/JDD.8587."

Journal • Alopecia • Dermatology • Immunology

Medicaid Insurance Coverage for Treatment of Alopecia Areata with Janus Kinase Inhibitors (AAD 2025) - "Alopecia areata (AA) is an autoimmune disorder causing patchy hair loss, with recently FDA-approved Janus kinase (JAK) inhibitors (baricitinib, ritlecitinib, and deuruxolitinib) enabling effective treatment of moderate-to-severe AA. Dermatologists should also champion policy updates to bridge the large coverage gap for baricitinib between AA and RA treatment. Advocacy efforts are needed to improve Medicaid coverage and ensure equitable access to JAK inhibitors for treating AA."

Medicaid • Reimbursement • US reimbursement • Alopecia • Dermatology • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

A Discrete Choice Experiment to Assess Clinician Preferences for the Treatment of Alopecia Areata (AAD 2025) - "Blinded profiles approximating baricitinib 4mg, ritlecitinib, and deuruxolitinib 8mg were ranked as most and least preferred. Our study demonstrated that, regarding JAK-inhibitor treatment of AA, clinicians preferred options with higher efficacy and shorter time to onset, regardless of daily or twice daily dosing."

Clinical • Alopecia • Dermatology • Immunology

SERUM ECM BIOMARKERS CORRELATE WITH ENDOSCOPIC RESPONSE TO RITLECITINIB IN PHASE-2 STUDIES OF UC AND CD (DDW 2025) - No abstract available

Biomarker • P2 data • Inflammatory Bowel Disease