A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Lichen Planopilaris

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with lichen planopilaris

Start Date19 Mar 2026

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT06978725

/ RecruitingPhase 2/3

A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Cutaneous Sarcoidosis

This study will evaluate the clinical safety and efficacy of oral brepocitinib in participants with cutaneous sarcoidosis.

Start Date09 Apr 2025

Sponsor / Collaborator

Priovant Therapeutics, Inc.

NCT06431373

/ Active, not recruitingPhase 3

A Phase 3 Randomized, Double-Masked, Placebo-Controlled Study to Investigate the Safety and Efficacy of Oral Brepocitinib in Adults With Active, Non-Infectious Intermediate-, Posterior-, and Panuveitis

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).

Start Date11 Sep 2024

Sponsor / Collaborator

Priovant Therapeutics, Inc.

100 Clinical Results associated with Brepocitinib

100 Translational Medicine associated with Brepocitinib

100 Patents (Medical) associated with Brepocitinib

Literatures (Medical) associated with Brepocitinib

03 Jul 2026·EXPERT OPINION ON PHARMACOTHERAPY

Emerging synthetic drugs for the management of hidradenitis suppurativa: a comprehensive update

Review

Author: Almansouri, Daifallah ; Naasani, Alaa ; Zouboulis, Christos C.

INTRODUCTION:

Hidradenitis suppurativa (HS) is a chronic, debilitating inflammatory skin disorder affecting intertriginous regions. Despite its substantial impact on quality of life and association with serious systemic comorbidities, undertreatment remains a concern. Currently, only three biologic agents - adalimumab, secukinumab, and bimekizumab - hold regulatory approval for moderate-to-severe HS. A large proportion of patients, however, fail to achieve adequate or sustained responses, representing an urgent unmet therapeutic need for novel drugs. Among them, new, orally bioavailable, synthetic small-molecule agents are emerging.

AREAS COVERED:

This review synthesizes current evidence on emerging oral synthetic drugs for HS, drawn from PubMed, ClinicalTrials.gov, congress abstracts, and peer-reviewed publications through March 2026. Mechanistic classes discussed include Janus kinase (JAK) inhibitors (povorcitinib, upadacitinib, ruxolitinib), TYK2 inhibitors (brepocitinib, ropsacitinib, deucravacitinib), PDE-4 inhibitors (apremilast, orismilast, roflumilast), BTK/SYK inhibitors (remibrutinib, fostamatinib), IRAK-4 inhibitors (zimlovisertib), and HSP-90 inhibitors (RGRN-305).

EXPERT OPINION:

Oral JAK1 inhibition represents the most advanced small-molecule strategy for HS treatment. The emergence of topical JAK inhibitors (ruxolitinib cream) for milder HS and the progression of BTK inhibitors (remibrutinib) to Phase 3 trials signal a broadening treatment landscape. Personalized selection of synthetic drugs versus biologics - informed by patient comorbidities, disease phenotype, and biomarkers - will be involved in next-generation HS management.

01 Jun 2026·Nature Reviews Rheumatology

Brepocitinib shows promise for dermatomyositis

Article

Author: Onuora, Sarah

14 May 2026·NEW ENGLAND JOURNAL OF MEDICINE

A Phase 3 Trial of Brepocitinib in Dermatomyositis

Article

Author: Mozaffar, Tahseen ; Fiorentino, David ; Campanilho-Marques, Raquel ; Haemel, Anna ; Gandiga, Prateek C. ; Bauer Ventura, Iazsmin ; Pearson, David ; Ernste, Floranne ; Boh, Erin ; Bozan, Francisca ; Sivakumar, Kumaraswamy ; Sluzevich, Jason ; Lee, Eun Bong ; Paik, Julie J. ; Fernandez, David R. ; Onajin, Oluwakemi ; Dimachkie, Mazen M. ; Schiopu, Elena ; Bubb, Michael R. ; Maganti, Rashmi ; Aggarwal, Rohit ; Shaw, Katharina S. ; Min, Michelle S. ; Vencovsky, Jiri ; Vleugels, Ruth Ann ; Hussain, Yessar M. ; Werth, Victoria P. ; Hsu, Chung-Yuan ; Luggen, Michael ; Mudd, Paul N. ; Femia, Alisa ; Charles-Schoeman, Christina ; Marder, Galina ; Cascino, Matthew D. ; Lindsey, Stephen ; Chinoy, Hector ; Fernandez, Anthony P. ; Christopher-Stine, Lisa ; Mangold, Aaron R. ; Heinlen, Latisha ; Griger, Zoltan

BACKGROUND:

Brepocitinib is a first-in-class, oral, selective TYK2-JAK1 inhibitor that blocks cytokine signaling, which has been implicated in dermatomyositis.

METHODS:

In this phase 3, double-blind, randomized, placebo-controlled trial, adults with dermatomyositis were assigned in a 1:1:1 ratio to receive once-daily oral brepocitinib at a dose of 30 mg, brepocitinib at a dose of 15 mg, or placebo for 52 weeks. Standard therapies were continued, and glucocorticoids were tapered. The primary end point was the Total Improvement Score, a validated composite myositis index (with scores ranging from 0 to 100 and higher scores indicating greater improvement) at week 52. Key secondary end points, including skin disease activity, glucocorticoid tapering, and physical function, were tested in a multiplicity-controlled sequence.

RESULTS:

A total of 241 patients underwent randomization: 81 to receive brepocitinib 30 mg, 81 to receive brepocitinib 15 mg, and 79 to receive placebo. At week 52, the mean Total Improvement Score was 46.5, 37.5, and 31.2, respectively (difference with brepocitinib 30 mg vs. placebo, 15.3; 95% confidence interval [CI], 6.7 to 24.0; P<0.001; difference with brepocitinib 15 mg vs. placebo, 6.3; 95% CI, -2.4 to 14.9). Brepocitinib 30 mg was superior to placebo across all nine key secondary end points, including skin disease activity, systemic glucocorticoid tapering, and functional disability, with improvements observed as early as week 4. Serious infections were more frequent in the brepocitinib 30-mg group than in the placebo group (10% vs. 1%). No deaths occurred during the trial.

CONCLUSIONS:

In adults with dermatomyositis that was resistant to previous therapy, the use of brepocitinib at a dose of 30 mg (but not at a dose of 15 mg) resulted in significant benefits with respect to a composite myositis index, skin disease severity, glucocorticoid tapering, and functional disability. (Funded by Priovant Therapeutics; ClinicalTrials.gov number, NCT05437263.).

129

News (Medical) associated with Brepocitinib

30 Aug 2026

·www.biospace.com

Orsini to Serve as Specialty Pharmacy Partner for Priovant’s LISRAYA™ (brepocitinib)

LISRAYA is the first FDA-approved targeted therapy for dermatomyositis. ELK GROVE VILLAGE, Ill. , Aug. 28, 2026 /PRNewswire/ -- Orsini, a leader in rare disease pharmacy solutions, announced today that it is a specialty pharmacy partner for Priovant's LISRAYA™ (brepocitinib), a once-daily oral therapy for the treatment of adults with dermatomyositis. Read the full Prescribing Information here . See the Important Safety Information and Boxed Warning below for complete safety information. "The approval of LISRAYA represents an incredible step forward for these patients and their care journey, and Orsini is thrilled to help meaningfully improve their quality of life," Orsini CEO Brandon Tom said. Dermatomyositis is a rare autoimmune inflammatory disease characterized by painful skin rashes and debilitating muscle weakness, as well as broader systemic manifestations such as lung disease, cardiac disease and gastrointestinal complications. LISRAYA represents the first targeted treatment option approved for dermatomyositis. It was tested in the VALOR study, the largest placebo-controlled dermatomyositis trial ever conducted. In VALOR, patients taking LISRAYA saw clinically meaningful improvement across a broad range of disease measures, including global myositis response, cutaneous disease, muscle strength, functional disability and steroid sparing. "We're excited to partner with Orsini in offering this potentially transformative therapy for the dermatomyositis community," Daniel Herz-Roiphe, Chief Operating Officer at Priovant, said. "This approval represents new hope for a population whose treatment options were previously very limited, and Orsini's deep experience in rare disease therapies will ensure that patients have a seamless experience as they gain access to LISRAYA." About Orsini Providing patients with comprehensive and compassionate care since 1987, Orsini is a leader in rare diseases and gene therapies. Orsini partners with biopharma innovators, healthcare providers and payors to support patients and their families in accessing revolutionary treatments for rare diseases. Through integrated rare disease pharmacy solutions including pharmacy distribution, patient services, clinical management and convenient home infusion services, Orsini simplifies how patients connect to advanced therapies. Orsini's high-touch care model centers on experienced and trained therapy care teams that provide personalized patient care to ensure that No Patient is Left Behind™ . Orsini holds accreditations with the Accreditation Commission for Health Care (ACHC), URAC and NABP. Orsini has earned URAC's Rare Disease Pharmacy Center of Excellence Designation and ACHC's Distinction in Rare Diseases and Orphan Drugs. For more information, visit IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE IMPORTANT SAFETY INFORMATION WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS INDICATIONS AND USAGE LISRAYA (brepocitinib) is indicated for the treatment of adults with dermatomyositis (DM). Limitations of Use Not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs. WARNINGS and PRECAUTIONS: Serious infections. Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death. Reported infections with use of Janus kinase (JAK) inhibitors, including LISRAYA: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Evaluate and test patients for latent and active TB infection prior to and during LISRAYA treatment. If positive, treat for TB. Monitor all patients for active TB during treatment including patients who tested negative for a latent TB infection prior to LISRAYA treatment. Invasive fungal infections. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens. Avoid use of LISRAYA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of LISRAYA in patients with chronic or recurrent infection prior to initiating treatment. Closely monitor patients for signs and symptoms of infection during and after treatment with LISRAYA. If a serious infection occurs, interrupt LISRAYA treatment until the infection resolves or is adequately treated. Mortality. A higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor when compared to tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA) 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Malignancy. Malignancies have occurred in patients treated with LISRAYA. A higher rate of malignancies (excluding non-melanoma skin cancer), lymphomas, and lung cancers was observed with another JAK inhibitor when compared to TNF blockers in patients with RA. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk. Major Adverse Cardiovascular Events (MACE). Major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) have occurred in patients treated with LISRAYA. A higher rate of MACE was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk. Discontinue LISRAYA in patients who have experienced a myocardial infarction or stroke. Thrombosis. Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including LISRAYA. Many of these adverse reactions were serious and some resulted in death. A higher rate of thromboses was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Avoid LISRAYA in patients who may be at risk of thrombosis. If symptoms of thrombosis occur, discontinue LISRAYA, promptly evaluate, and appropriately treat. Hypersensitivity. LISRAYA is contraindicated in patients with known hypersensitivity to brepocitinib or any of its excipients. Hypersensitivity reactions were reported in patients receiving LISRAYA. Some events were serious. Gastrointestinal Perforations. Gastrointestinal perforation has been reported in patients treated with JAK inhibitors, including LISRAYA. Monitor LISRAYA-treated patients who may be at risk for gastrointestinal perforation. Hypoglycemia in Patients with Diabetes. LISRAYA may cause hypoglycemia in patients with diabetes. Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. During treatment with LISRAYA, consider increased monitoring of blood glucose as clinically indicated in patients with diabetes. Laboratory Abnormalities. LISRAYA has been associated with lab abnormalities including neutropenia, lymphopenia, anemia, increases in lipid parameters, and liver enzyme elevations. Immunizations. Avoid use of live vaccines during or immediately prior to LISRAYA therapy initiation. Prior to initiating LISRAYA treatment, update immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, according to current immunization guidelines. Embryofetal Toxicity. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LISRAYA and for 3 days following the last dose. ADVERSE REACTIONS The most common adverse reactions occurring in ≥5% of DM subjects and ≥2% greater than placebo were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne. SPECIAL POPULATIONS Pregnancy. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Available data from LISRAYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Lactation. There are no data on the presence of brepocitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Hepatic Impairment. LISRAYA is not recommended in patients with severe hepatic impairment. Renal Impairment. LISRAYA is not recommended in patients with severe renal impairment. Please see the Full Prescribing Information , including BOXED WARNING, and Medication Guide . View original content to download multimedia: SOURCE Orsini

Drug ApprovalOrphan Drug

28 Aug 2026

·www.prnewswire.com

Orsini to Serve as Specialty Pharmacy Partner for Priovant's LISRAYA™ (brepocitinib)

LISRAYA is the first FDA-approved targeted therapy for dermatomyositis. ELK GROVE VILLAGE, Ill., Aug. 28, 2026 /PRNewswire/ -- Orsini, a leader in rare disease pharmacy solutions, announced today that it is a specialty pharmacy partner for Priovant's LISRAYA™ (brepocitinib), a once-daily oral therapy for the treatment of adults with dermatomyositis. Read the full Prescribing Information here. See the Important Safety Information and Boxed Warning below for complete safety information. "The approval of LISRAYA represents an incredible step forward for these patients and their care journey, and Orsini is thrilled to help meaningfully improve their quality of life," Orsini CEO Brandon Tom said. Dermatomyositis is a rare autoimmune inflammatory disease characterized by painful skin rashes and debilitating muscle weakness, as well as broader systemic manifestations such as lung disease, cardiac disease and gastrointestinal complications. LISRAYA represents the first targeted treatment option approved for dermatomyositis. It was tested in the VALOR study, the largest placebo-controlled dermatomyositis trial ever conducted. In VALOR, patients taking LISRAYA saw clinically meaningful improvement across a broad range of disease measures, including global myositis response, cutaneous disease, muscle strength, functional disability and steroid sparing. "We're excited to partner with Orsini in offering this potentially transformative therapy for the dermatomyositis community," Daniel Herz-Roiphe, Chief Operating Officer at Priovant, said. "This approval represents new hope for a population whose treatment options were previously very limited, and Orsini's deep experience in rare disease therapies will ensure that patients have a seamless experience as they gain access to LISRAYA." About Orsini Providing patients with comprehensive and compassionate care since 1987, Orsini is a leader in rare diseases and gene therapies. Orsini partners with biopharma innovators, healthcare providers and payors to support patients and their families in accessing revolutionary treatments for rare diseases. Through integrated rare disease pharmacy solutions including pharmacy distribution, patient services, clinical management and convenient home infusion services, Orsini simplifies how patients connect to advanced therapies. Orsini's high-touch care model centers on experienced and trained therapy care teams that provide personalized patient care to ensure that No Patient is Left Behind™. Orsini holds accreditations with the Accreditation Commission for Health Care (ACHC), URAC and NABP. Orsini has earned URAC's Rare Disease Pharmacy Center of Excellence Designation and ACHC's Distinction in Rare Diseases and Orphan Drugs. For more information, visit . IMPORTANT SAFETY INFORMATION and INDICATION AND USAGE WARNINGS and PRECAUTIONS: Serious infections. Patients treated with LISRAYA are at increased risk of developing serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death. Reported infections with use of Janus kinase (JAK) inhibitors, including LISRAYA: Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Evaluate and test patients for latent and active TB infection prior to and during LISRAYA treatment. If positive, treat for TB. Monitor all patients for active TB during treatment including patients who tested negative for a latent TB infection prior to LISRAYA treatment. Invasive fungal infections. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens. Avoid use of LISRAYA in patients with an active, serious infection, including localized infections. Consider the risks and benefits of LISRAYA in patients with chronic or recurrent infection prior to initiating treatment. Closely monitor patients for signs and symptoms of infection during and after treatment with LISRAYA. If a serious infection occurs, interrupt LISRAYA treatment until the infection resolves or is adequately treated. Mortality. A higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor when compared to tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis (RA) 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Malignancy. Malignancies have occurred in patients treated with LISRAYA. A higher rate of malignancies (excluding non-melanoma skin cancer), lymphomas, and lung cancers was observed with another JAK inhibitor when compared to TNF blockers in patients with RA. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk. Major Adverse Cardiovascular Events (MACE). Major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) have occurred in patients treated with LISRAYA. A higher rate of MACE was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Patients who are current or past smokers are at additional increased risk. Discontinue LISRAYA in patients who have experienced a myocardial infarction or stroke. Thrombosis. Thromboses, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with JAK inhibitors, including LISRAYA. Many of these adverse reactions were serious and some resulted in death. A higher rate of thromboses was observed with another JAK inhibitor when compared to TNF blockers in patients with RA 50 years of age and older with at least one cardiovascular risk factor. LISRAYA is not approved for use in patients with RA. Avoid LISRAYA in patients who may be at risk of thrombosis. If symptoms of thrombosis occur, discontinue LISRAYA, promptly evaluate, and appropriately treat. Hypersensitivity. LISRAYA is contraindicated in patients with known hypersensitivity to brepocitinib or any of its excipients. Hypersensitivity reactions were reported in patients receiving LISRAYA. Some events were serious. Gastrointestinal Perforations. Gastrointestinal perforation has been reported in patients treated with JAK inhibitors, including LISRAYA. Monitor LISRAYA-treated patients who may be at risk for gastrointestinal perforation. Hypoglycemia in Patients with Diabetes. LISRAYA may cause hypoglycemia in patients with diabetes. Hypoglycemia, including severe hypoglycemia, has been reported following initiation of JAK inhibitors in patients with diabetes. During treatment with LISRAYA, consider increased monitoring of blood glucose as clinically indicated in patients with diabetes. Laboratory Abnormalities. LISRAYA has been associated with lab abnormalities including neutropenia, lymphopenia, anemia, increases in lipid parameters, and liver enzyme elevations. Immunizations. Avoid use of live vaccines during or immediately prior to LISRAYA therapy initiation. Prior to initiating LISRAYA treatment, update immunizations, including prophylactic varicella zoster or herpes zoster vaccinations, according to current immunization guidelines. Embryofetal Toxicity. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to starting treatment. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LISRAYA and for 3 days following the last dose. ADVERSE REACTIONS The most common adverse reactions occurring in ≥5% of DM subjects and ≥2% greater than placebo were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, fall, influenza, and acne. SPECIAL POPULATIONS Pregnancy. Based on findings in animal studies, LISRAYA may cause fetal harm when administered to a pregnant woman. Available data from LISRAYA use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Lactation. There are no data on the presence of brepocitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Hepatic Impairment. LISRAYA is not recommended in patients with severe hepatic impairment. Renal Impairment. LISRAYA is not recommended in patients with severe renal impairment. Please see the Full Prescribing Information , including BOXED WARNING, and Medication Guide . SOURCE Orsini 21% more press release views with Request a Demo

28 Aug 2026

·www.biopharmadive.com

FDA green lights Priovant drug for rare skin disease

The Food and Drug Administration on Thursday cleared the first oral therapy for a rare and debilitating skin condition.Called brepocitinib and to be sold as Lisraya, the drug was originally discovered by Pfizer and licensed to Priovant Therapeutics, a subsidiary of hub-and-spoke biotechnology company Roivant Sciences. Its been cleared for use treating dermatomyositis, a condition that causes muscle weakness and skin lesions. A 30-day supply will have a list price of $35,000, executives revealed on a Friday conference call.In a July interview with BioPharma Dive, Roivant CEO Matt Gline described the success biotechs like BridgeBio Pharma, Argenx and Insmed have had marketing their own drugs as a blueprint for Priovant. We don't have to be an innovator commercially, we just have to learn from what other people have done and reproduce it, Gline said at the time.Taken once daily, Lisraya targets TYK2 and JAK1, two members of the family of Janus kinase or JAK proteins. Multiple drugs that block JAK proteins have been approved to treat autoimmune conditions like rheumatoid arthritis and eczema and some, like AbbVies Rinvoq, have become big sellers. But theyve also been associated with serious safety issues.Rather than challenge these drugs in broader immune conditions, Priovant zeroed in on rarer diseases with Lisraya. Its been testing the drug in dermatomyositis as well as other inflammatory eye and skin disorders, where theres less competition and approval paths might be quicker.Weve chosen some markets that we've been able to pioneer, where theyre wide open and the unmet need is high, Gline said. They were well-tailored to the biological nature of the drug.Dermatomyositis affects an estimated 34,000 people in the U.S. and is typically managed with steroids, immunoglobulin infusions and the off-label use of certain immunosuppressive drugs. In Phase 3 testing, Priovant found that, over the course of a year, a 30 milligram daily dose of Lisraya was associated with better scores on a scale evaluating muscle strength, function, skin health and other signs of disease. More people taking Lisraya were also able to cut down or eliminate steroid use.Additional data published in JAMA this week revealed more benefits on skin-related disease symptoms. About three-quarters of trial participants reported a clinically meaningful improvement in itching after a year on treatment, compared to 33% of enrollees taking a placebo. And nearly half of patients with moderate-to-severe skin disease at the studys start achieved remission-level outcomes over that course of time, Priovant said.For too long, patients with dermatomyositis have faced a significant unmet need for effective treatments, often relying on therapies meant for other diseases, said Nikolay Nikolov, the director of the FDA office that evaluates immunology and inflammation drugs, in a statement. Todays approval is a meaningful step forward, giving patients and their healthcare providers an approved oral therapy proven to help manage this rare and debilitating disease.The most common side effects for people taking Lisraya included infection, headache, fatigue, nausea and diarrhea. Testing showed Lisrayas safety profile was consistent with other JAK inhibitors, Priovant said.The drugs prescribing information included the same kind of boxed warning as other JAK blockers. There were no major surprises in the label, and notably, all important secondary endpoints were included, wrote Leerink Partners analyst David Risinger in a Thursday client note.Editors note: This story has been updated with pricing information. '

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Brepocitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11537	-	-	DB15003

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dermatomyositis	United States	Priovant Therapeutics, Inc.	27 Aug 2026

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Sarcoidosis	NDA/BLA	United States	Roivant Sciences Ltd.	06 Feb 2026
Lichen Planus Follicularis	Phase 3	United States	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	Australia	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	Canada	Priovant Therapeutics, Inc.	19 Mar 2026
Lichen Planus Follicularis	Phase 3	United Kingdom	Priovant Therapeutics, Inc.	19 Mar 2026
Non-infectious posterior uveitis	Phase 3	United States	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Argentina	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Australia	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Austria	Priovant Therapeutics, Inc.	11 Sep 2024
Non-infectious posterior uveitis	Phase 3	Belgium	Priovant Therapeutics, Inc.	11 Sep 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05437263 (VALOR, EULAR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	ychoxohjqi(hvmonzzbzo) = tzktjtqeqt gvkiqjgxur (xdvjdyxydq ) View more	Positive	11 Jun 2026
				Placebo	sjsugxoiru(sagbzefhtq) = hziqjdaptu xosocuzrlh (fadkpfeske ) View more
VALOR (EULAR2026)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	olmifycekb(erxlucalhk) = gpytrwquix odomlprnie (oqrekojogx ) View more	Positive	11 Jun 2026
				Placebo	olmifycekb(erxlucalhk) = pzxezjwivd odomlprnie (oqrekojogx ) View more
NCT05437263 (Pubmed \| N Engl J Med)	Phase 3	Dermatomyositis	241	Brepocitinib 30 mg	yaplpgnupe(uqlpdhgfjd) = dndatgripm fpislqhhaz (kburpvvrcq ) View more	Positive	14 May 2026
				Brepocitinib 15 mg	yaplpgnupe(uqlpdhgfjd) = bmvwwcmdcp fpislqhhaz (kburpvvrcq )
NCT05437263 (N Engl J Med \| GlobeNewswire) Manual	Phase 3	Dermatomyositis	241	brepocitinib 30 mg	avaffovnxh(xkjempklah) = jbkhnsbren dzuiljiwcv (dwtpwprkxa ) Met View more	Positive	28 Mar 2026
				brepocitinib 15 mg	avaffovnxh(xkjempklah) = nxoybytivt dzuiljiwcv (dwtpwprkxa ) Met
AAD2026	Phase 2/3	Hidradenitis Suppurativa IL-23 \| JAK/STAT \| C5a	6,129	Brepocitinib	-	Positive	27 Mar 2026
				Porvocitinib
NCT05437263 (VALOR, Company_Website) Manual	Phase 3	Dermatomyositis	187	Brepocitinib 30 mg	skabzbdgnh(hoseojieih) = lcyavshixf walanmteet (keycjhmwfh )	Positive	17 Sep 2025
				Placebo	skabzbdgnh(hoseojieih) = jeonodxlmc walanmteet (keycjhmwfh )
NCT03395184 (CTgov)	Phase 2	Crohn Disease	244	Placebo (Induction Period: Placebo QD)	mhtrzpytpd = azxvitniwn wdnndcqufq (gsvsayqelv, oydrucobib - libbowwiwh) View more	-	30 Oct 2024
				Ritlecitinib (Induction Period: Ritlecitinib 200 mg/50 mg QD)	mhtrzpytpd = sjepwzsota wdnndcqufq (gsvsayqelv, svxzmpyclc - dyolvbtbzi) View more
NCT05523765 (NEPTUNE, EURETINA2024)	Phase 2	Non-infectious anterior uveitis	26	Brepocitinib 45 mg	qpnxjxzseb(wwlsvrqzav) = tapnackxhd nlgzmqlwfi (uerjchxgqu, 10.3 - 56.0)	Positive	19 Sep 2024
				Brepocitinib 15 mg	qpnxjxzseb(wwlsvrqzav) = eyqmwbziyv nlgzmqlwfi (uerjchxgqu, 13.7 - 78.8)
NCT03845517 (CTgov)	Phase 2	Systemic Lupus Erythematosus	350	Placebo (Placebo)	ttbyywvsln = jsfdjzeujy oeiycibusi (durwzmmuhq, vteyogmmex - zhyaxnvklt) View more	-	05 Sep 2024
				PF-06700841 15 mg (PF-06700841 15 mg)	ttbyywvsln = dvldxmaelx oeiycibusi (durwzmmuhq, jtfeuggtdl - asejrmizwm) View more
NCT05523765 (NEPTUNE, Biospace) Manual	Phase 2	Uveitis	26	brepocitinib 45 mg	zbtzkidmwr(pxsnvkunjc) = piaeahbakm besmyopatv (velrtosujc ) Met View more	Positive	02 Apr 2024

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