Delving into the Latest Updates on Upadacitinib hemihydrate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Upadacitinib Hydrate, Upadacitinib tartrate, 乌帕奴单抗

+ [8]

Target

JAK1

Action

inhibitors

Mechanism

JAK1 inhibitors(Tyrosine-protein kinase JAK1 inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesCongenital Disorders+ [9]

Active Indication

Giant Cell ArteritisPolyarticular Juvenile Idiopathic ArthritisCrohn's disease, active moderate+ [23]

Inactive Indication

DyssomniasLupus Nephritis

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie Deutschland GmbH & Co. KG

AbbVie, Inc.AbbVie LLC

+ [4]

Inactive Organization-

License Organization-

Drug Highest PhaseApproved

First Approval Date

United States (16 Aug 2019),

Rheumatoid Arthritis

RegulationOrphan Drug (United States), Breakthrough Therapy (China), Priority Review (China), Special Review Project (China)

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Structure/Sequence

Molecular FormulaC34H40F6N12O3

InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N

CAS Registry2050057-56-0

This is a Phase IV, open-label, multicenter study evaluating the impact of upadacitinib on the frequency of acute anterior uveitis (AAU) in adults with axial spondyloarthritis (axSpA) and a documented history of AAU in the prior 52 weeks. Approximately 200 participants will be enrolled across North America and Europe, including both biologic DMARD-inadequate responders (bDMARD-IR) and bDMARD-naïve patients. The primary objective is to assess the change in exposure-adjusted AAU event rate during 52 weeks of treatment with upadacitinib 15 mg once daily. Secondary objectives include evaluating the effect of upadacitinib on disease activity, pain, physical function, quality of life, and sleep. Safety and tolerability will also be assessed throughout the study.

Start Date01 May 2026

Sponsor / Collaborator

Canadian Research and Education (CaRE Arthritis).

ChiCTR2600118874

/ RecruitingNot ApplicableIIT

Efficacy and Safety of Upadacitinib versus Tofacitinib in Refractory Systemic Juvenile Idiopathic Arthritis: A Multicentre, Randomized, Controlled Clinical Trial

Start Date15 Feb 2026

Sponsor / Collaborator

Children’S Hospital Of Chongqing Medical University

NCT07258771

/ RecruitingPhase 4IIT

Acute Severe Ulcerative Colitis- Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction While Transitioning Away From the Emergency Setting (ACUTE): A Phase IV, Single Center, Partially Blinded, Randomized Study

This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC).
This research is studying multiple drugs already approved by the Food and Drug Administration (FDA). The goal of this study is to test the early efficacy and safety of upadacitinib (Rinvoq) and corticosteroids compared to corticosteroids alone as induction therapy for both inpatients and outpatients with ASUC.

Start Date16 Jan 2026

Sponsor / Collaborator

University of Michigan

[+1]

100 Clinical Results associated with Upadacitinib hemihydrate

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100 Translational Medicine associated with Upadacitinib hemihydrate

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100 Patents (Medical) associated with Upadacitinib hemihydrate

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1,555

Literatures (Medical) associated with Upadacitinib hemihydrate

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

From signal to strategy: a disproportionality analysis of dupilumab-associated rosacea in FAERS with a summary of reported clinical cases

Review

Author: Yang, Xuefan ; Ruan, Dandan ; Chen, Xiang ; Li, Sitong ; Lin, Jiacheng ; Qiu, Xinlan ; Li, Jiaqi ; Ju, Qiang ; Mo, Xiaohui

PURPOSE:

Emerging evidence suggests rosacea as a recognizable adverse event during dupilumab therapy. This study aimed to investigate the potential association between dupilumab and rosacea using pharmacovigilance data and to characterize the clinical features of dupilumab-associated rosacea (DAR) through a review of reported cases.

MATERIALS AND METHODS:

We utilized the FDA Adverse Event Reporting System (FAERS) database (2017-2024) to identify disproportionality signals using four methods: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Information Component (IC), and Empirical Bayesian Geometric Mean (EBGM). To contextualize these findings, we performed a focused narrative review of 8 publications comprising 10 DAR cases with extractable individual data.

RESULTS:

A significant disproportionality signal was identified across all four methods (ROR 3.873; PRR 3.872; IC 1.865 with IC025 1.653; EBGM 3.642), with reports predominantly in adults and females. In the case review, a consistent phenotype emerged: papulopustules on persistent centrofacial erythema with frequent burning; facial predominance with occasional extension to neck, scalp, or upper trunk; frequent Demodex detection by scraping, KOH, or in vivo imaging; and occasional granulomatous histology. Onset ranged from approximately 2 weeks to 21 months, including one post-discontinuation case. Most patients improved with rosacea-directed therapy (topical ivermectin or metronidazole; anti-inflammatory-dose doxycycline). However, dechallenge or rechallenge patterns and the need for dose-interval extension, temporary interruption, or switching biologic (e.g., lebrikizumab, upadacitinib) in a subset support a drug-related pattern at the reporting level.

CONCLUSIONS:

DAR represents a distinct clinical entity from dupilumab-associated head and neck dermatitis, which is eczematous and typically responds to antifungals or calcineurin inhibitors. While disproportionality signals indicate association rather than incidence or causality and are subject to reporting bias, clinicians should be aware of this potential adverse event to ensure appropriate management.

31 Dec 2026·JOURNAL OF DERMATOLOGICAL TREATMENT

Dose-dependent effectiveness and patient-reported outcomes with JAK1 inhibitors in atopic dermatitis: a 36-week multicenter real-world cohort

Article

Author: Ulutaş Demirbaş, Gözde ; Esen, Mustafa ; Diremsizoglu, Esin ; Demirbaş, Abdullah

BACKGROUND:

Dose-stratified real-world data for JAK1 inhibitors in AD are limited.

OBJECTIVE:

To compare effectiveness and safety of standard vs high doses of abrocitinib and upadacitinib in routine care.

METHODS:

Multicenter, retrospective cohort study. The primary endpoint was Week-12 achievement of Eczema Area and Severity Index (EASI)-75. Secondary outcomes included patient-reported improvements at Minimal Clinically Important Difference (MCID) thresholds, Minimal Disease Activity (MDA) at Week 36, time-to-EASI-75, and treatment-emergent adverse events(TEAE).

RESULTS:

A total of 124 patients were analyzed (abrocitinib 100 mg, n = 28; abrocitinib 200 mg, n = 32; upadacitinib 15 mg, n = 30; upadacitinib 30 mg, n = 34). At Week 12, EASI-75 was achieved in 20/32 (62.5%) versus 10/28 (35.7%) for abrocitinib (OR 2.94, 95% CI 1.06-8.15; p = 0.036) and in 22/34 (64.7%) versus 14/30 (46.7%) for upadacitinib (OR 2.92, 95% CI 1.16-7.38; p = 0.021), favoring the higher-dose regimens. Itch improvement was more frequent with higher doses. By Week 36, full minimal disease activity was observed in 30.2% of patients receiving abrocitinib 200 mg and 26.7% receiving upadacitinib 30 mg, compared with 18.4% and 20.0% in the lower-dose groups. Kaplan-Meier analysis showed faster responses with high doses (median 12 vs 36 weeks; log-rank p < 0.01). Safety was comparable across groups.

CONCLUSION:

High-dose JAK1 regimens achieve faster, numerically greater disease control without short-term safety tradeoffs, supporting escalation in suboptimal responders.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-utility and budget impact analysis of dupilumab and oral Janus kinase (JAK) inhibitors for treating moderate-to-severe atopic dermatitis in Taiwan

Article

Author: Lee, John Tayu ; Wu, David Bin-Chia ; Shen, Toby Kai-Bo ; Yang, Rachel Ai-Ting ; Tan, Hsiao-Hsiao ; Liu, Valerie Tzu-Ning ; Wang, Yen Hsiang

BACKGOROUND:

Atopic dermatitis (AD), a chronic inflammatory skin disease, affects 1.28% of Taiwan's population, with 26.69% having moderate-to-severe cases, causing significant healthcare costs and quality-of-life impairments. Conventional treatments often fail these patients, necessitating novel therapies like dupilumab and Janus kinase (JAK) inhibitors (abrocitinib, baricitinib, upadacitinib). This study evaluates the cost-utility and budget impact of these therapies versus best supportive care (BSC) for adults with moderate-to-severe AD from Taiwan's NHI perspective.

METHODS:

A hybrid decision tree-Markov model assessed short- and long-term (Years 1-20) outcomes using trial efficacy, NHI costs (2022 NT$), and EQ-5D utilities. Interventions included topical corticosteroids/calcineurin inhibitors. Outcomes were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs), discounted at 3%, with a NT$2,000,000/QALY threshold. Sensitivity analyses tested robustness. A five-year (2026-2030) budget impact analysis (BIA) included epidemiology and market uptake.

RESULTS:

Upadacitinib 30 mg was most cost-effective (11.0782 QALYs, ICER NT$1,250,903/QALY vs BSC), followed by Upadacitinib 15 mg (NT$1,376,435/QALY). Dupilumab was dominated; Baricitinib's ICERs exceeded NT$2,000,000/QALY. Sensitivity analyses confirmed robustness, with utility gains, medication costs, and discontinuation rates as key drivers. The BIA estimated a NT$117 billion incremental impact, driven by drug costs, with per-patient increments falling from NT$339,769 to NT$264,728.

CONCLUSION:

Upadacitinib 30 mg was the most cost-effective option for moderate-to-severe atopic dermatitis in Taiwan, but its high budget impact underscores the need for strategic pricing and reimbursement policies to ensure long-term affordability and access.

486

News (Medical) associated with Upadacitinib hemihydrate

05 Feb 2026

·www.biopharmadive.com

Earnings roundup: AbbVie angst, a bifurcated vaccine market and Bristol Myers’ waiting game

With quarterly earnings underway, BioPharma Dive is providing a snapshot of some companies results and how theyre being received by investors. Today, were offering insight into the latest numbers from Bristol Myers Squibb, GSK and AbbVie.AbbVie angstAbbVie reported $16.6 billion worth of net revenue in the final three months of 2025, a 10% year-over-year increase. The total was a bit above what analysts generally predicted, with the vast majority of revenue upside coming from a surprise performance by Humira, according to David Risinger of Leerink Partners.Once the worlds best-selling drug, Humira has been in decline since generic competition entered the market a few years ago. But in the fourth quarter, the $1.2 billion the drug brought in was almost 30% higher than Wall Street expectations.Most of AbbVies other products were roughly in-line with estimates, with one exception being Rinvoq, which fell below with a quarterly revenue of nearly $2.4 billion. Those performances may be why company shares were, at one point Wednesday, down more than 6%.Phipps, of William Blair, highlighted how it was the second quarter in a row that Rinvoq didnt meet analyst forecasts. At the same time, Skyrizi the other immune system-regulating drug AbbVie has pegged as a partial successor to Humira had only a slight beat.Investors continue to have concerns about growing competition for the companys [immunology] franchises, Phipps wrote in a note to clients. One particular point of worry, he added, is how Rinvoq and Skyrizi will fare in the inflammatory bowel disease market since the relatively recent entries of Johnson & Johnsons Tremfya and copycat versions of Stelara.AbbVie recorded $61.2 billion in net revenue across all of 2025, reflecting an 8.6% annual gain. For this year, the company said adjusted diluted earnings per share will land somewhere between $14.37 to $14.57.Though such a range should be viewed positively by investors, Cantor Fitzgeralds Carter Gould argues that the focus is more on the revenue and product-level guides, especially for Skyrizi. Jacob BellA bifurcated vaccine marketVaccine makers are facing a unique challenge in one of their largest markets. The sudden, drastic shift in U.S. vaccine policy, combined with growing skepticism and declining immunization rates, has imperiled sales as well as future vaccine research.Moderna CEO Stephane Bancel has already reportedly said his company wont invest in late-stage vaccine trials due to the contentious climate. Now, some of the worlds top vaccine manufacturers are reporting slowing sales numbers that could provide insight into how the situation will play out in the coming years.Last week, French pharmaceutical Sanofi said that vaccine sales fell 2.5% in the fourth quarter and are anticipating negative sales growth next year. Thats in large part due to performance in the U.S., where revenue dipped for immunizations against polio, meningitis, influenza and respiratory syncytial virus.GSK is now reporting similar trends.The British drugmaker said Wednesday that while overall vaccine sales were up 2% in the fourth quarter, its growth was driven by sales in Europe and elsewhere, while U.S. numbers tumbled for its influenza, RSV and shingles vaccines. Its shingles vaccine, Shingrix, faced the sharpest decline, with sales plummeting 17% in the U.S. due to heightening difficulty reaching unvaccinated individuals.While the earnings for adult shots were the most affected, GSK has yet to see how the new changes to the U.S. childhood immunization schedule will affect the rest of GSKs vaccines. Nina Mojas, head of the companys global product strategy, said the impact should be manageable given its broad vaccine portfolio.“We continue to monitor the evolving pediatric vaccine landscape in the U.S, Mojas said during an earnings call.Last month, the Centers for Disease Control and Prevention rolled back six immunization recommendations for children in response to a directive from President Trump. The schedule was scaled down to recommend 11 vaccines from the previous 17.At least so far, however, insurance coverage remains as before, Mojas added. GSK expects vaccine sales to either be stable or decline by a low-single digits percent in 2026. Delilah AlvaradoBristol Myers waiting gameBristol Myers growth portfolio lived up to its name in 2025, helping the company deliver fourth-quarter and full-year revenues that were a tick higher than analyst estimates.The portfolio spans 18 products, most of which are used to treat cancer or regulate the immune system. Collectively, revenue from this group rose 17% last year, and accounted for 55% of the total $48.2 billion Bristol Myers recorded. Standout performances, according to William Blair analyst Matt Phipps, came from the anemia shot Reblozyl, the heart drug Camzyos and the cell therapy Breyanzi.Wall Street had hoped to see Cobenfy, a first-of-its-kind treatment for schizophrenia that generated $51 million in the fourth quarter, bring in a bit more during that three-month period. Bristol Myers took control of Cobenfy back in 2024, through an acquisition worth $14 billion. The company has been looking to ramp up sales by notching additional approvals in more common conditions like bipolar disorder or the agitation, psychosis and cognition problems that often accompany Alzheimers disease.A trio of late-stage studies evaluating Cobenfy against Alzheimers psychosis are set to produce results this year. Analysts have pinpointed those trials as some of Bristol Myers most important near-term catalysts, along with Phase 3 readouts for the companys experimental myeloma drugs iberdomide and mezigdomide and its blood thinner milvexian.We see the continued outperformance of the growth portfolio as a positive signal on execution, with attention pointing to [back half of the year] datasets for further confidence on the mid- to long-term revenue trajectory, wrote Raymond James analyst Sean McCutcheon in a note to clients.Bristol Myers is under pressure to further build out that portfolio, given the steep declines across most of its legacy drugs like Revlimid and Pomalyst. Its top-seller, Eliquis, is also poised to lose key patent protections in 2028, putting more than a quarter of Bristol Myers annual revenue in jeopardy.For 2026, the company forecasts revenue reaching around $46 billion to $47.5 billion and non-GAAP earnings per share in the range of $6.05 to $6.35. Those figures are in line to moderately above Wall Street expectations, McCutcheon wrote.Shares of Bristol Myers climbed more than 3% Thursday. Jacob Bell '

AcquisitionVaccinePhase 3Clinical ResultCell Therapy

04 Feb 2026

·www.fiercepharma.com

AbbVie, hitting record sales on Skyrizi gains, holds its own in growing IBD arena despite J&J competition

The Illinois-based drugmaker pulled $61.1 billion in 2025 sales. Billions of dollars in U.S. biosimilar erosion to AbbVie’s blockbuster immunology drug Humira is no match for its rising superstar Skyrizi. Despite the fall of what was once the world’s top-selling drug, one thing is certain: AbbVie’s immunology portfolio is still on top.In the two years since Humira first faced biosimilar competition, AbbVie’s newer Skyrizi and Rinvoq have more than picked up the slack. In 2025, the duo propelled the company to a record-breaking $61.1 billion in total sales, an 8.6% increase over 2024 that eclipsed the company’s previous peak revenue of $58 billion in 2022. The new landmark was reached despite nearly $16 billion of U.S. Humira erosion that has set in since then, CEO Robert Michael said on AbbVie’s fourth-quarter and full-year earnings conference call. Together, Skyrizi, Rinvoq and Humira made up $30.4 billion of those sales, representing 14% year-over-year growth. Although Humira sales dissipated to $4.5 billion over the year, Skyrizi pulled far ahead to $17.5 billion, while Rinvoq is chugging along with $8.3 billion in yearly sales.The trio helped the company surpass its initial 2025 guidance by more than $2 billion, Michael pointed out. IBD competitive dynamicsOne of the biggest growth drivers of sales for both Skyrizi and Rinvoq is the inflammatory bowel disease (IBD) market, an umbrella term that constitutes both Crohn’s disease and ulcerative colitis. Skyrizi specifically holds an in-play capture rate of 75% among IL-23 drugs in the frontline IBD setting, chief commercial officer Jeffrey Stewart said, touting a “strong and consistent” share performance even as the IL-23 drug class “grows rapidly.”One such IL-23 that makes formidable competition for the immunology duo across the same indications is Johnson & Johnson’s Tremfya. The drug, which J&J positioned to take on sales from older Stelara à la AbbVie’s Humira strategy, rounded out its IBD uses with a Crohn’s disease nod early last year, solidifying its competitive label in the IBD market.But despite the competitive entrant, Stewart maintained that Skyrizi’s dominance over new patient starts in the frontline setting suggests that Tremfaya is more so capturing second-line shares, he explained.“Our compete level is extremely high, and we're very, very comfortable with the momentum that we're going to continue to see with Skyrizi,” the executive said.For its part, Tremfya locked down $5.2 billion in 2025 sales for J&J, reflecting a rapid 40% growth from 2024. Brushing off the competition from other IBD contenders, Michael maintained that Skyrizi isn’t playing in a “zero-sum game” despite the crowded market. The CEO pointed to Skyrizi’s ongoing head-to-head ulcerative colitis trial with Takeda’s monoclonal antibody Entyvio as a “significant opportunity to continue the momentum” of the fast-growing drug, while Stewart noted that Skyrizi’s dosing convenience is “often favored” above other similar treatment options.The company also put particular emphasis on Rinvoq in IBD as well, as Stewart highlighted that the med has demonstrated “some of the strongest response rates to date in IBD.” Together, the Skyrizi-Rinvoq duo make for “a great pair,” with Skyrizi tackling the frontline area and Rinvoq having “more opportunity than ever before” in second-line treatment, Stewart said.In psoriasis, meanwhile, the company is confident that its portfolio has “clear leadership,” Stewart said, citing Skyrizi’s 45% of total prescription share within the U.S. biologic market for the disease in the fourth quarter.Although Rinvoq’s sales are far behind Skyrizi’s, the drug could have a new market opportunity of its own in non-segmental vitiligo, a chronic, progressive autoimmune disease that causes unpredictable skin depigmentation. The company recently filed regulatory bids with the FDA and the European Medicines Agency (EMA), positioning Rinvoq as potentially the first systemic treatment for the disease, AbbVie said.Elsewhere, the company made sure to highlight its Parkinson’s disease treatment, Vyalev, and its broader neuroscience portfolio. The therapy was approved in 2024 and collected sales of $482 million in 2025, but AbbVie is forecasting a “substantial sales ramp” that will result in blockbuster status this year. Given Vyalev’s “outstanding launch,” Stewart said that the company's Parkinson's disease portfolio “remains underappreciated.” Michael concurred, citing a “profound opportunity to lead in neuroscience for the long term,” which is “clearly not reflected in Street models.”The company expects total sales growth of 9.5% to $67 billion in 2026, chief financial officer Scott Reents said on the call, with Skyrizi and Rinvoq leading the charge along with Vyalev. Given the expected gains within the company’s “diverse portfolio,” AbbVie is charging high single-digit revenue growth through 2029, Michael added. Skyrizi and Rinvoq, once expected to capture $31 billion in 2027, are now on track to pick up $34.5 billion in 2026, Reents said.AbbVie is “disappointed” that its Botox franchise made the latest list of drugs that will face price cuts under the Inflation Reduction Act (IRA), given that the plasma-derived product “should have been excluded,” Michael said. However, the CEO noted that the selection does not impact the company’s long-term growth guidance.

Drug Approval

04 Feb 2026

·endpoints.news

AbbVie says immunology blockbusters will be 'main drivers' of growth post-Humira

AbbVie says its newer immunology products are making up for Humira’s loss of patent exclusivity. Combined, Skyrizi and Rinvoq have exceeded peak Humira sales by more than $4.5 billion, executives said Wednesday on the company’s fourth-quarter earnings call. AbbVie CEO Rob Michael said he expects them to be “main drivers” of growth in 2026, potentially generating more than $31 billion. In the wake of Humira’s patent cliff, Skyrizi and Rinvoq have taken the mantle as the company’s top sellers. Skyrizi put up $5 billion in fourth-quarter sales, a 33% growth from the same period last year and slightly beating analysts’ consensus estimates. Rinvoq brought in $2.4 billion, a 30% increase, though that drug came in below analysts’ forecasts by about $20 million, according to a report from Leerink. The company’s stock $ABBV was down 3% on Wednesday afternoon. William Blair analyst Matt Phipps told Endpoints News that while both Rinvoq and Skyrizi are growing “very impressively,” investors “are worried that that is starting to temper a little bit.” “Investors have been used to more robust growth from Skyrizi and Rinvoq,” Phipps said. Skyrizi and Rinvoq have been on the market for seven years. They’re used to treat a range of conditions, including psoriatic arthritis, ulcerative colitis and Crohn’s disease. Humira won its first approval in 2002 and is used for a wide range of autoimmune conditions. It faced its first biosimilar rival in 2023, but still generates billions of dollars per year for AbbVie. However, executives expect the blockbuster will continue to see its revenue decline in 2026. Phipps said investors are worried about competition for Skyrizi and Rinvoq, particularly from Johnson & Johnson’s Tremfya in irritable bowel disease. But AbbVie’s chief commercial officer Jeffrey Stewart said on the earnings call that Skyrizi continues to see “very stable and high new patient starts despite the competitive entrant.” Meanwhile, Humira sales totaled $1.2 billion for the fourth quarter, beating analysts’ consensus. Humira sales declined 26% from the fourth quarter last year primarily due to biosimilar competition.

Drug ApprovalBiosimilarClinical ResultPatent Expiration

100 Deals associated with Upadacitinib hemihydrate

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KEGG	Wiki	ATC	Drug Bank
D10994 D11048	Upadacitinib hemihydrate	L04AA44	DB15091

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Giant Cell Arteritis	European Union	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Iceland	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Giant Cell Arteritis	Norway	AbbVie Deutschland GmbH & Co. KG	08 Apr 2025
Polyarticular Juvenile Idiopathic Arthritis	United States	AbbVie, Inc.	26 Apr 2024
Crohn's disease, active moderate	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active moderate	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	European Union	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Iceland	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Crohn's disease, active severe	Norway	AbbVie Deutschland GmbH & Co. KG	24 Apr 2023
Moderate Atopic Dermatitis	United States	AbbVie, Inc.	14 Jan 2022
Severe Atopic Dermatitis	United States	AbbVie, Inc.	14 Jan 2022
Crohn Disease	Canada	AbbVie AS	16 Jan 2020
Ankylosing Spondylitis	European Union	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Iceland	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019
Ankylosing Spondylitis	Norway	AbbVie Deutschland GmbH & Co. KG	16 Dec 2019

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonsegmental vitiligo	NDA/BLA	United States	AbbVie, Inc.	03 Feb 2026
Nonsegmental vitiligo	NDA/BLA	European Union	AbbVie, Inc.	03 Feb 2026
Dyssomnias	Phase 3	-	AbbVie, Inc.	23 May 2024
Alopecia Areata	Phase 3	United States	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	China	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	Japan	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	Argentina	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	Australia	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	Belgium	AbbVie, Inc.	11 Oct 2023
Alopecia Areata	Phase 3	Brazil	AbbVie, Inc.	11 Oct 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05601882 (LEVEL UP, Pubmed \| Am J Clin Dermatol)	-	Dermatitis, Atopic	208	Upadacitinibdupilumab (Moderate-to-Severe Atopic Dermatitis + Inadequate response to dupilumab)	fbjkrbytfp(ldxhgjvnxc) = qksxcgywzc bseejapdmo (flmdhvktyg ) View more	Positive	14 Jan 2026
NCT06227910 (VICTRIVA, Pubmed \| Contemp Clin Trials Commun)	Phase 3	Crohn Disease	396	Vedolizumab + Upadacitinib	uiswecjmpg(poooponqij) = evcjbkbrkc mdgdjpfnwk (otjscqedce ) View more	Positive	01 Dec 2025
				Vedolizumab	aroxmheiod(aoeeezrjzi) = lodqlermzr ovtdviomhn (gfzosmpdyy ) View more
NCT02819635 \| NCT03345849 \| NCT03345836 \| NCT03653026 \| NCT03345823 (U-EXCEED, Pubmed \| J Crohns Colitis)	Phase 2/3	Ulcerative colitis, active severe \| Perianal fistula due to Crohn's disease	2,480	Upadacitinib 45 mg	rfcyumtwqr(mkvsrkagtt) = AESI rates were generally comparable between UPA and PBO across subgroups except for numerically higher rates of herpes zoster and serious infections in CD with UPA wwpluacnqh (qjfypoqjto )	Positive	20 Nov 2025
				Placebo
NCT03345849 (U-EXCEL, Pubmed \| Inflamm Bowel Dis)	Phase 3	Crohn's disease, active severe	1,021	Upadacitinib 45 mg	nlmrzcafjv(rgtuzxiwvj) = mwjpjblvvc rwbanbgbnf (jdyoogmoey ) View more	Positive	04 Nov 2025
				Placebo	nlmrzcafjv(rgtuzxiwvj) = nzqkddudvy rwbanbgbnf (jdyoogmoey ) View more
NCT06118411 (Viti-Up, Company_Website) Manual	Phase 3	Vitiligo	614	Upadacitinib 15 mg (Study 1)	icwfhckmda(kxktbbecpo) = cxhxxytoir bnkrwagtwt (nmlusotxmg ) Met View more	Positive	29 Oct 2025
				Placebo (Study 1)	icwfhckmda(kxktbbecpo) = mknmiviavt bnkrwagtwt (nmlusotxmg ) Met View more
ACR2025	Not Applicable	Salivary Gland Adenoma, Pleomorphic	985	Baricitinib (B) (RA + PsA)	vwetwzweds(pazrtjvwim) = Adverse events were in line with this class of immune suppressive therapies including VTE, where PE outnumber DVT events. wbfsliamzx (qxgxwvxoad )	Positive	24 Oct 2025
				Tofacitinib (T) (RA + PsA)
NCT03978520 (SLEek, ACR2025)	Phase 2	Systemic Lupus Erythematosus	137	Upadacitinib 30 mg	xocbwifunb(irvkwfsroh) = erlefnbaod yiplaenoza (khzfibxsgx, 3.4 - 14.7) View more	Positive	24 Oct 2025
				Placebo	xocbwifunb(irvkwfsroh) = gbojpfsjjk yiplaenoza (khzfibxsgx, −1.9 - 8.0) View more
NCT03978520 (SLEek, ACR2025)	Phase 2	Systemic Lupus Erythematosus	137	Upadacitinib 30 mg	wahigersdx(snmyyvrtnz) = luvqozoete xsxoqmjfnj (gkoppsloaf ) View more	Positive	24 Oct 2025
				Placebo	wahigersdx(snmyyvrtnz) = srqeibtllj xsxoqmjfnj (gkoppsloaf ) View more
SELECT-PsA 1 (ACR2025)	Phase 3	Arthritis, Psoriatic	1,704	Upadacitinib 15mg	ntarysvnel(hzakxtfvqx) = cdvlpqukjn hpqcjpycik (qnhrfnvxiq ) View more	Positive	24 Oct 2025
				Upadacitinib 30mg	tjlerdcwgq(vmiwacibax) = fvmjbxebhv jfihrqyybk (jnocdtnedl )
SELECT-AXIS 1 (ACR2025)	Phase 3	Axial Spondyloarthritis	460	Upadacitinib 15 mg once daily (bDMARD-naïve r-axSpA)	ipdscvnhhe(bjtcryguey) = ozamfecbxt oqsgidfjga (sfsdkwroxf ) View more	Positive	24 Oct 2025
				Upadacitinib 15 mg once daily (bDMARD-IR r-axSpA)	ipdscvnhhe(bjtcryguey) = nklejpvkos oqsgidfjga (sfsdkwroxf ) View more