Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

and immunology regulatory activity accelerated from July through September 2026. The 

 extended Ryaltris (olopatadine/mometasone) to children aged 6 to 11 years with seasonal allergic rhinitis, accepted marketing applications for lonvo-z and oral deucrictibant in hereditary angioedema (HAE), and granted Fast Track designation to Aravax's PVX108 for peanut allergy.

Aquestive resubmitted its Anaphylm New Drug Application (NDA), and a WAO Delphi panel endorsed ED05-based precautionary allergen labeling. HCPLive features examined Palforzia's discontinuation, the delayed allergic toll of wildfire smoke, and why anaphylaxis guidelines lag behind epinephrine nasal spray.

Explore this quarter's top allergy news, FDA updates, clinical trial data, and expert insights below.

FDA Ryaltris Pediatric Approval in Allergic Rhinitis

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

The FDA expanded the approval of Ryaltris (olopatadine hydrochloride and mometasone furoate; Glenmark Pharmaceuticals) nasal spray to include seasonal allergic rhinitis in children aged 6 to 11 years, the company announced July 21, 2026. The fixed-dose antihistamine and corticosteroid combination was first approved in 2022 for patients aged ≥ 12 years.

Approval was supported by a phase 3, randomized, double-blind, placebo-controlled trial of 446 children, in which 1 spray per nostril twice daily improved nasal symptoms vs placebo over 14 days and was well tolerated. The most common adverse reactions were dysgeusia, epistaxis, and nasal discomfort.

Lonvo-z and Deucrictibant HAE New Drug Applications Accepted by FDA

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

The FDA accepted the Biologics License Application for lonvoguran ziclumeran (lonvo-z; Intellia Therapeutics) with priority review for HAE in patients aged ≥16 years, setting a PDUFA date of March 10, 2027. If approved, the one-time CRISPR/Cas9 therapy targeting KLKB1 would be the first in vivo gene-editing treatment for HAE, and the FDA does not currently plan an advisory committee.

In the phase 3 HAELO trial, a single 50 mg dose reduced mean monthly attacks by 87% vs placebo. Overall, 62% of treated patients remained attack-free and therapy-free through 6 months vs 11% with placebo, and all adverse events were mild or moderate.

What CRISPR Gene Therapy Means for HAE: FAQ on This 1-Time Treatment

FDA Accepts NDA for Oral Deucrictibant for HAE Attacks

The FDA accepted Pharvaris' NDA for deucrictibant immediate-release capsules, an oral bradykinin B2 receptor antagonist for on-demand treatment of HAE attacks, with a PDUFA date of April 23, 2027. If approved, it would become the first oral agent in its class for acute HAE attacks.

The phase 3 RAPIDe-3 trial, which enrolled patients aged ≥ 12 years, including those with normal C1 inhibitor levels, met its primary endpoint and all 11 secondary efficacy endpoints. Median time to onset of symptom relief was 1.28 hours, and median time to complete attack resolution was 11.95 hours.

Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

The FDA granted Fast Track designation to PVX108 (Aravax), an investigational peptide immunotherapy for peanut allergy, on August 3, 2026. Built from 7 short synthetic fragments of the major peanut allergen, PVX108 contains no whole allergen or extract and is administered intradermally once monthly without dose escalation.

In the phase 1 AVX-001 trial of 67 peanut-allergic adults, no serious adverse events occurred, and mild injection site reactions were the only event more frequent than with placebo. Exploratory analyses showed peanut-reactive T cells shifting toward tolerance, and topline phase 2 data are expected later in 2026.

Aquestive Resubmits Anaphylm NDA for Anaphylaxis Treatment

Aquestive Therapeutics resubmitted its NDA for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine prodrug for type I allergic reactions including anaphylaxis, on September 17, 2026. The resubmission responds to a January 30, 2026 Complete Response Letter (CRL) requesting a packaging-focused human factors study and a confirmatory pharmacokinetic study.

Revised packaging cut median pouch-opening time from 17 seconds to 3 seconds, and no protocol-defined use errors occurred in the self-administration arm. The FDA has not yet classified the resubmission or set a review timeline.

Anaphylm Is Back at the FDA: A Clinician FAQ on Needle-Free Epinephrine

WAO Delphi Consensus on Precautionary Allergen Labeling

WAO Delphi Consensus Endorses ED05-Based Allergen Labelling

A World Allergy Organization (WAO) ACT-UP! e-Delphi panel of 35 experts across 21 countries reached consensus on 33 of 35 statements on precautionary allergen labeling. The panel recommended "may contain" warnings apply only when a mandatory risk assessment shows unintended allergen presence exceeding an action level based on ED05 reference doses, the amount estimated to trigger objective reactions in ≤5% of allergic individuals.

Panelists rejected a fixed 5 ppm cutoff, while 10 ppm failed to reach consensus. "May contain X" emerged as the preferred wording, and 97% agreed free-from labels should mean no detectable allergen.

Palforzia Discontinuation, Wildfire Smoke, and Neffy Guideline Gap

Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp), the first and only FDA-approved oral immunotherapy (OIT) for peanut allergy, was discontinued as of July 31, 2026. Stallergenes Greer said the withdrawal was unrelated to safety, quality, or efficacy. 

 spoke to experts on what this discontinuation means for the allergy field.

How Wildfire Smoke Triggers Allergic Disease Long After It Clears

Smoke from Canadian wildfires blanketed the East Coast and Midwest in summer 2026, and emerging research suggests its allergic toll can outlast the haze. HCPLive spoke with environmental health experts on wildfire smoke’s impact on allergies.

Wildfire Smoke's Hidden Toll on Patients with Allergies

Epinephrine Nasal Spray Available, but Anaphylaxis Guidelines Lag

Epinephrine nasal spray (neffy) received FDA approval on August 9, 2024, but formal anaphylaxis practice parameters have not yet incorporated it. HCPLive spoke with allergists on how to counsel patients about epinephrine nasal spray before anaphylaxis guidelines catch up.

Articles

Regulatory momentum intensified in allergy/immunology, led by pediatric label expansion for intranasal combination therapy in allergic rhinitis and advancing HAE programs spanning one-time gene editing and first-in-class oral acute therapy. Peanut allergy development saw both disruption and acceleration, with cessation of the only FDA-approved OIT and Fast Track support for peptide-based immunotherapy. Needle-free epinephrine progressed via NDA resubmission addressing human factors and PK requirements. Global experts moved toward ED05-driven, risk-assessed precautionary allergen labeling, alongside heightened attention to wildfire smoke’s prolonged allergic sequelae.

Ryaltris pediatric approval, lonvo-z and deucrictibant HAE filings, PVX108 Fast Track, and Palforzia's exit headline Q3 2026 allergy news.

News

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Clinical

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Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

FDA News

Q3 2026 Recap: Allergy News and Updates

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Upadacitinib (Rinvoq) treatment at 15 mg and 30 mg produces higher placebo-adjusted response rates than nemolizumab (Nemluvio) across skin and itch treatment targets through Week 16 in adults and adolescents with moderate to severe 

 receiving background topical corticosteroids, according to a matching-adjusted indirect comparison.¹

2026 European Academy of Dermatology and Venereology (EADV) Congress

.¹ The AbbVie-funded analysis, first presented at the Revolutionizing Atopic Dermatitis (RAD) Conference in June 2026, was led by Jonathan I. Silverberg, MD, PhD, MPH, of George Washington University School of Medicine and Health Sciences. The findings were presented as Poster P1668. No head-to-head trial has compared the oral Janus kinase 1 inhibitor with the interleukin 31 receptor alpha antagonist.¹

How Did Investigators Compare Upadacitinib and Nemolizumab?

The team used individual patient data from the phase 3 AD Up trial (NCT03568318), in which patients received upadacitinib 15 mg, upadacitinib 30 mg, or placebo with topical corticosteroids for 16 weeks.¹˒² Because patient-level nemolizumab data were unavailable, investigators relied on published aggregate results from the phase 3 ARCADIA 1 and 2 trials of nemolizumab 30 mg.¹˒³

Upadacitinib patients were weighted to mirror nemolizumab trial populations on disease severity scores, age, weight, sex, race, and quality of life. All trials required an EASI score of 16 or higher, at least 10% body surface area, and a Worst Pruritus Numerical Rating Scale (WP-NRS) score of 4 or higher.¹

Outcomes followed the Aiming High in Eczema/Atopic Dermatitis (AHEAD) framework. Moderate targets included EASI-75, a WP-NRS improvement of 4 points or more, and both combined, while optimal targets were EASI-90 and a WP-NRS score below 2. Comparisons relied on placebo-adjusted risk differences with nonresponder imputation.¹

Before placebo adjustment, matching-adjusted EASI-75 rates at Week 16 were 68.3% with upadacitinib 15 mg and 79.2% with upadacitinib 30 mg, compared with 42.9% reported for nemolizumab in ARCADIA.¹

At the 16-week mark, placebo-adjusted EASI-75 response reached 40.8 percentage points with upadacitinib 15 mg and 51.8 points with upadacitinib 30 mg, compared with 13.4 points with nemolizumab. For EASI-90, the corresponding values were 33.7, 54.9, and 8.0 points.¹

Itch outcomes followed a similar pattern. Placebo-adjusted rates for a WP-NRS improvement of at least 4 points were 40.4 and 48.6 points with the 2 upadacitinib doses versus 24.0 points with nemolizumab, and rates for a WP-NRS score below 2 were 31.4 and 42.2 points versus 18.3 points.¹

For the combined skin and itch target, placebo-adjusted response was 36.2 and 48.5 points with upadacitinib versus 12.8 points with nemolizumab. Risk differences favored both upadacitinib doses across all 5 outcomes (P < .001).¹

Significant differences favoring upadacitinib appeared by Week 2 for both itch endpoints and by the fourth week for EASI-75, EASI-90, and the combined skin and itch target. These differences held at every subsequent assessment through Week 16.¹

What Limitations Should Clinicians Consider?

Patients in the ARCADIA trials could use topical calcineurin inhibitors alongside corticosteroids and completed a topical run-in period before baseline, both of which the authors acknowledged could bias results. Indirect comparisons also cannot account for unmeasured differences between trial populations.¹

The WP-NRS score below 2 endpoint was derived specifically for this analysis to match ARCADIA reporting, since AD Up originally reported WP-NRS 0/1. AbbVie funded the study, and several authors are company employees.¹

Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.

Silverberg JI, Bunick CG, Chovatiya R, et al. Comparative efficacy of upadacitinib and nemolizumab in combination with background topical therapy in adults and adolescents with moderate-to-severe atopic dermatitis: a placebo-anchored matching-adjusted indirect comparison. Poster P1668. Presented at: 2026 European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.

Silverberg JI, et al. J Allergy Clin Immunol. 2022;143(3):977-987.

Silverberg JI, et al. Lancet. 2024;404(10451):445-460.

Upadacitinib 15 mg and 30 mg demonstrated larger placebo-adjusted improvements than nemolizumab 30 mg across AHEAD-aligned skin and pruritus targets through Week 16 in moderate-to-severe atopic dermatitis on background topical corticosteroids. Using a placebo-anchored matching-adjusted indirect comparison, upadacitinib favored nemolizumab for EASI-75/90, WP-NRS improvements, and combined skin-plus-itch response, with early separation by Week 2 for itch. Interpretation is constrained by cross-trial differences, endpoint harmonization, and sponsor involvement.

An indirect comparison finds higher placebo-adjusted skin and itch responses with upadacitinib vs nemolizumab in atopic dermatitis.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Upadacitinib Tops Nemolizumab on Skin, Itch Targets in Indirect Analysis

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Pulmonology has seen significant growth over the past few months, with the acceptance of major New Drug Applications by the 

 and a series of major conferences around the world. With so much new data and so many major headlines published over the last 3 months, the 

 editorial team has compiled 8 of the most impactful stories from the third quarter of 2026. As we move into the fourth and final quarter of the year, catch up on anything you may have missed below:


FDA Accepts sBLA for Clesrovimab-cfor in Second RSV Season


On August 6, 2026, the FDA accepted a supplemental Biologics License Application for clesrovimab-cfor, an extended half-life monoclonal antibody, to expand its indication and add prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in patients ≤2 years of age at increased risk of severe RSV through their second RSV season. Announced by parent company Merck, the FDA has set a PDUFA target action date of March 22, 2027.


FDA Fast Tracks LTI-03 for Idiopathic Pulmonary Fibrosis


On August 20, the FDA granted Fast Track designation to LTI-03, an inhaled peptide therapy, for idiopathic pulmonary fibrosis (IPF). This decision followed an Orphan Drug designation already granted to LTI-03. It also came during the enrollment process for RENEW, a phase 3 trial investigating LTI-03 for changes in forced vital capacity from baseline.


FDA Updates Sotatercept Label with HYPERION Data in Early PAH


On September 22, the FDA approved a label update for sotatercept-csrk for 

. The new label includes efficacy and safety data from the phase 3 HYPERION trial, which demonstrated sotatercept’s efficacy in reducing the risk of clinical worsening events compared to placebo. While the activin signaling inhibitor already carries approval for adults with PAH to improve exercise capacity and reduce clinical worsening events, the HYPERION trial specifically targeted patients earlier in their disease course, leading to the label update.


Semaglutide Cuts Asthma Attacks by up to 40% in Real-World Study


A real-world analysis of UK electronic health records has indicated semaglutide’s association with a ≤40% reduction in 

chronic obstructive pulmonary disease (COPD)

 flare-ups compared to sulfonylureas. While prior research has indicated that GLP-1s have possible anti-inflammatory effects that may improve lung-related outcomes, the present analysis more directly addresses semaglutide’s efficacy in reducing airway exacerbations.


Verekitug's TSLP Mechanism and VALIANT Trial Results, With Michael Wechsler, MD


Upstream Bio’s investigational monoclonal antibody verekitug, developed to target the thymic stromal lymphopoietin (TSLP) receptor, met its primary endpoint of reducing annualized asthma exacerbation rates in the phase 2 VALIANT trial. In a Q&A with the 

 editorial team, Michael Wechsler, MD, MMSc, professor of medicine and director of the Cohen Family Asthma Institute at National Jewish Health, discusses the drug’s mechanism and the trial’s key safety and efficacy findings.


Zumilokibart Rapidly Suppresses FeNO in Phase 1b Asthma Data: Mario Castro, MD


Another presentation from the European Respiratory Society International Congress, this one by Mario Castro, MD, MPH, professor of medicine at the University of Kansas School of Medicine, highlighted new topline interim findings from a phase 1b trial of zumilokibart in mild to moderate asthma. The long-acting anti-interleukin-13 monoclonal antibody in development by Apogee Therapeutics demonstrated rapid and sustained suppression of fractional exhaled nitric oxide in this patient population, effectively outperforming placebo.


AI-Powered ECG and Echo Could Shrink 2.5-Year Diagnostic Delay in PH


PAH possesses an average diagnostic delay of roughly 2.5 years, due in large part to the subtlety of early symptoms and low index of suspicion across primary care and subspecialty settings. To combat this, AI-powered devices such as Mayo Clinic’s PH Early Detection Algorithm are in development to detect signals in brightness and contrast gradients of waveform data, thereby detecting signs of PAH before symptoms become apparent. In an interview with 

, Andaleeb Chowdhury, MD, assistant professor of medicine at the Lewis Katz School of Medicine at Temple University, discusses just how close these and similar models are to clinical deployment.


Closing the AATD Diagnostic Gap, With Sarah Tomashefski, MSN

Alpha-1 antitrypsin deficiency (AATD) is among the most persistently underdiagnosed genetic conditions in pulmonology, with >90% of patients with severe disease undiagnosed and delays taking roughly 8-10 years from symptoms to confirmed testing. In a Q&A with the 

 editorial team, Sarah Tomashefski, MSN, AGNP-C, lead outpatient pulmonary advanced practice provider at Prisma Health in Greenville, South Carolina, discussed where these diagnoses go missed and how clinicians can work to close this gap.

Pulmonology drug development and clinical practice are advancing rapidly, spanning pediatric RSV prevention, fibrotic lung disease, and earlier intervention in PAH. Regulatory momentum includes an expanded-season sBLA for clesrovimab and Fast Track for inhaled LTI-03 in IPF, alongside a sotatercept label update incorporating HYPERION outcomes. New evidence suggests semaglutide may reduce airway exacerbations in real-world settings, while biologics targeting TSLP receptor and IL-13 show promising asthma signals. Persistent diagnostic delays in PAH and AATD are being addressed via AI tools and improved testing pathways.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Videos

8 Pulmonology Headlines You Missed in Q3 2026

 in Vienna, Austria, delivered new long-term efficacy data, pregnancy safety findings, and expert perspectives across psoriasis, cutaneous lupus erythematosus, and atopic dermatitis.

Highlights included 2-year data for an oral interleukin (IL)-23 receptor-blocking peptide at hard-to-treat psoriasis sites, 52-week results for a novel antibody in refractory cutaneous lupus, final findings from a 7-year dupilumab pregnancy registry, and 2 conversations with Leon Kircik, MD, on an investigational oral agent and the broader atopic dermatitis landscape.

ICONIC-TOTAL: Icotrokinra Sustains High-Impact Site Clearance at 2 Years

Once-daily oral icotrokinra maintained clearance through Week 112 in plaque psoriasis involving the scalp, genitals, hands and feet, and nails, according to late-breaking results from the phase 3 ICONIC-TOTAL trial. Among patients randomized to icotrokinra, 70% had clear or almost clear skin at Week 112, and complete clearance rates at that point reached 60% for scalp, 89% for genital, and 63% for hand and foot disease. Nail severity improved by 71%, and exposure-adjusted adverse event rates did not rise with longer treatment.

AMETHYST: Litifilimab Sustains CLE Gains at 52 Weeks, With Victoria Werth, MD

Victoria Werth, MD, of the University of Pennsylvania, discussed 52-week data from AMETHYST Part A, a phase 2 study of subcutaneous litifilimab in cutaneous lupus erythematosus refractory or intolerant to antimalarials. Among patients who started the drug during the double-blind period, CLASI-50 response rose from 40.8% at Week 24 to 46.0% at Week 52, and patients who crossed over from placebo began responding within about 4 weeks. Werth emphasized the significance of a potential new option in a disease with no new approved therapies in more than 80 years.

No Signal for Birth Defects in Dupilumab Pregnancy Registry, With Tina Chambers, PhD, MPH

Final results from a prospective pregnancy registry run from 2018 to 2025 found no evidence of increased risk for major structural birth defects with dupilumab exposure, according to Christina Chambers, PhD, MPH, of UC San Diego. Compared with women who had the same underlying conditions but no dupilumab exposure, the weighted relative risk was 0.77 (95% CI, 0.40-1.50) among 539 enrolled participants. Chambers noted the registry finished recruitment in 5 years, far faster than the decade or more pregnancy safety data often require.

First-in-Class Oral ENV-294 Evaluated in Atopic Dermatitis, With Leon Kircik, MD

Kircik discussed phase 1b open-label data for ENV-294, an investigational oral Rac2 modulator, in 9 patients with moderate to severe atopic dermatitis. After 28 days of monotherapy, EASI scores fell by 68%, and the reduction deepened to 85% at day 42, 2 weeks after treatment ended. The only adverse event was a single mild headache. Kircik urged cautious optimism given the small sample, noting a placebo-controlled phase 2 trial is enrolling.

Oral Options, TYK2 Inhibitors, and Atopic Dermatitis Innovations, With Leon Kircik, MD

In a second segment of his interview, Kircik stepped back to look at the broader atopic dermatitis field, identifying oral therapies as a key unmet need, particularly for children averse to injections. He described the pace of innovation as much faster than psoriasis experienced during its early biologic era. Among emerging agents, he highlighted newer TYK2 inhibitors and rezpegaldesleukin, a first-in-class agent acting on the IL-2 receptor complex now also being studied in alopecia areata.

The EADV 2026 dermatology updates underscored sustained efficacy of novel systemic therapies and maturing safety evidence. A once-daily oral IL-23 receptor–blocking peptide maintained durable clearance through 112 weeks in high-impact psoriasis sites without rising exposure-adjusted adverse events. In refractory cutaneous lupus, a subcutaneous antibody showed continued CLASI responses through 52 weeks with rapid onset after crossover. A 7-year registry found no increased major birth-defect risk with dupilumab. Early phase data suggested potential for an oral Rac2 modulator in atopic dermatitis, amid expanding oral and TYK2 pipelines.

Check out highlights from news published on Day 3 of the EADV Congress 2026, spanning psoriasis, cutaneous lupus, atopic dermatitis, and more.

EADV Congress 2026: Day 3 Recap—5 Headlines to Know

Ritlecitinib 100 mg achieved F-VASI75 in 21.9% of patients versus 2.4% with placebo at week 52.

The Tranquillo program enrolled 2174 patients, many with skin types 3 through 6.

Serious adverse event rates were similar between ritlecitinib and placebo.

Oral ritlecitinib produced significantly higher facial and total body repigmentation rates than placebo at Week 52 in adults and adolescents with 

, according to phase 3 results from the Tranquillo program presented as a late-breaking abstract at the 

Iltefat H. Hamzavi, MD, of the Multicultural Dermatology Center at Henry Ford Health and Hamzavi Dermatology Specialists in Detroit, Michigan, is the abstract's first author. He spoke with 

 at the meeting about why the program represents a milestone for the field.

Phase 3 Ritlecitinib Results in Vitiligo, With Iltefat Hamzavi, MD

Why Does the Tranquillo Program Matter for Vitiligo?

Hamzavi described Tranquillo as the first systemic vitiligo study ever announced, unveiled at the Vitiligo International Symposium in Detroit around 2018. Bringing it to completion required years of effort to establish vitiligo as a disease worthy of this level of investment and to document its burden on patients, he explained.

The program enrolled 2174 patients across 271 sites, which Hamzavi said exceeds any prior randomized controlled trial in vitiligo.¹ He also expects it to be the largest study he knows of including patients with Fitzpatrick skin types 3 through 6, capturing disease burden in both lighter and darker skin.

Hamzavi credited patients, clinicians, industry, regulators, and especially patient communities for persisting through a lengthy study design. He noted he helped develop the Vitiligo Area Scoring Index (VASI) approach used for the primary end points and disclosed this as a conflict of interest.

Ritlecitinib is an oral Janus kinase 3 (JAK3) and TEC family kinase inhibitor. Eligible patients had nonsegmental vitiligo for at least 3 months, 4% - 60% body surface area involvement, and at least 0.5% facial involvement.¹

In Tranquillo 2 Part Ia (NCT06072183), adults were randomized 3:1:1 to ritlecitinib 100 mg (n = 622), ritlecitinib 50 mg (n = 206), or placebo (n = 208) for 52 weeks. At Week 52, 21.9% of the 100 mg group attained at least 75% improvement in Facial VASI (F-VASI75) versus 2.4% with placebo, and 13.0% versus 2.4% achieved Total VASI50 (T-VASI50; both 

Patient-reported facial severity response was 42.9% with the 100 mg dose versus 18.3% with placebo, and overall vitiligo severity response was 32.3% versus 17.3% (

 < .05 for both). Comparisons between the 50 mg dose and placebo in this analysis were not alpha-controlled.¹

In Tranquillo (NCT05583526), individuals aged 12 years and older were randomized 2:1 to be treated with ritlecitinib 50 mg (n = 401, including 26 adolescents) or a placebo (n = 202, including 13 adolescents). F-VASI75 rates at Week 52 were 12.5% as opposed to 2.5% (

 < .000001), and T-VASI50 rates were 9.0% versus 2.0% (

Percent change in both F-VASI and T-VASI separated from placebo by Week 24 and continued improving through Week 52. Patient-reported severity responses favored ritlecitinib for both the face (35.0% vs 12.2%) and overall vitiligo (23.3% vs 16.6%; 

What Safety Findings Were Reported with Ritlecitinib?

In Tranquillo 2 Part Ia, treatment-emergent adverse events occurred in 67.7%, 60.0%, and 62.0% of the 100 mg, 50 mg, and placebo groups, respectively, with serious events in 3.4%, 2.9%, and 3.4%. Upper respiratory tract infection, nasopharyngitis, and headache were most common.¹

In Tranquillo, adverse event rates were 81.0% with ritlecitinib and 77.1% with placebo, and serious events occurred in 2.0% and 2.5%, respectively. Upper respiratory tract infection, increased blood creatine phosphokinase, and nasopharyngitis were reported most frequently.¹

Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools. Iltefat Hamzavi is a consultant for AbbVie, Pfizer, Incyte, UCB, Boehringer Ingelheim, Sonoma, Merck, Takeda,Teva, Novartis, Jansen, Avita, Galderma, Vimela, and Almirall; an investigator for Pfizer, Incyte, Avita, L'Oréal/La Roche-Posay, ITN, and AbbVie; and a board member and past president of the Hidradenitis Suppurativa and Global Vitiligo foundations. 

Hamzavi I, Rosmarin D, Passeron T, et al. Efficacy and safety of ritlecitinib in patients with nonsegmental vitiligo (NSV): results from the Tranquillo 2 Part Ia and Tranquillo phase 3 randomized, double-blind, placebo-controlled, multicenter clinical trials. Abstract LB-161. Presented at: 2026 European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.

Iltefat H. Hamzavi, MD, discusses phase 3 Tranquillo data showing higher facial and total body repigmentation with ritlecitinib in vitiligo.

Vitiligo

Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 30 days.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

8 Pulmonology Headlines You Missed in September 2026

Werth discusses what the 52-week AMETHYST Part A data add to the case for litifilimab in antimalarial-refractory cutaneous lupus erythematosus.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Cardiology

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Cardiomyopathy

Dyslipidemia

9 Cardiology Headlines You Missed in Q3 2026

Mike Hess, MPH, RRT, RPFT, senior director of advocacy and regulatory affairs at the COPD Foundation.

On World Oxygen Day, the COPD Foundation's Mike Hess outlines the stigma, training gaps, and Medicare barriers affecting patients on supplemental oxygen.

Why Oxygen Stigma Persists, With Mike Hess, MPH

Mandana Khalili, MD, is Chief of Clinical Hepatology and Director of Clinical and Translational Research in Hepatology at San Francisco General Hospital, and directs the UCSF T32 Hepatology Training Program.

Drinking fell for the first time since COVID-19, but not for adults 50 to 64. Hepatologists explain what clinicians can do to close the gap.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Strategic Alliance Partnership

The Liver Keeps the Score: Americans Are Drinking Less, but Alcohol-Associated Liver Disease May Lag

From a pediatric alopecia areata approval to head-to-head TYK2 data at EADV, here are 7 dermatology stories from September 2026. 

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

Alopecia

7 Dermatology Headlines You Missed in September 2026 

Stay up-to-date with the latest in FDA decisions, trial readouts, and key clinician insights from all corners of endocrinology.

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8 Endocrinology Headlines You Missed in September 2026

Professor of pediatrics at University of California, San Diego and Vice Chair of Clinical Research for the Department of Pediatrics at UCSD and Rady Children's Hospital

Chambers discusses final results from a 7-year dupilumab pregnancy registry showing no evidence of increased risk for major birth defects or other outcomes.

Here, we review the top psychiatry news in September 2026, from DT120's second Breakthrough Therapy designation to the FDA psychedelic hearing.

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