RegulationOrphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Special Review Project (China)

Structure/Sequence

Molecular FormulaC34H40F6N12O3

InChIKeyGJMQTRCDSIQEFK-SCDRJROZSA-N

CAS Registry2050057-56-0

222

Clinical Trials associated with Upadacitinib hemihydrate

NCT07700446

/ Not yet recruitingPhase 4

A Single Arm, Multicenter Open-Label Interventional to Evaluate the Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose

ReCOUP is a multicenter clinical study designed to evaluate the efficacy of upadacitinib (Rinvoq®) in patients with ulcerative colitis whose disease has become active again despite maintenance treatment with upadacitinib 30 mg.
This study involves adult patients aged 18 to 64 years with active ulcerative colitis, who are being treated with upadacitinib and are not participating in another interventional clinical trial.
Participation in this study will depend on the patients' response to treatment during the 52-week maintenance period.
Several follow-up visits will be scheduled throughout the study according to a timetable defined by the protocol, and additional visits may be arranged if necessary depending on patients' health status.

Start Date15 Nov 2026

Sponsor / Collaborator

Getaid

CTIS2026-525221-21-01

/ Not yet recruitingPhase 4IIT

Optimising Arthritis Strategies in Elderly patients (≥70 years) with rheumatoid arthritis in sustained low disease activity (the OASE study): A Prospective Target Trial Emulation Study Evaluating Tapering of Disease-Modifying Anti-Rheumatic Drugs vs. Usual Care Based on Patient Preference

Start Date01 Oct 2026

Sponsor / Collaborator

Aalborg University Hospital

NCT06016517

/ Not yet recruitingNot ApplicableIIT

Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis

The goal of this N-of-1 study is to learn about treatment for individual patients who have rheumatoid arthritis (RA,) for which many treatments are available. The treatments are different in how they work, the way they are given, side- effects, and cost. While treatment guidelines are available, finding the best treatment order of treatments is often based on physician choice. The main question this study aims to answer are:
* What are the effects of different treatments on RA symptoms and condition for each individual patient
* What is the effectiveness of different treatments across all patients enrolled in the N-of-1 study
Participants will be enrolled and randomized to a sequence of three U.S. Food and Drug Administration (FDA) approved RA medications: 1. etanercept, 2. adalimumab, 3. upadacitinib 4. tocilizumab. Participants will be asked to complete questionnaires about their condition and quality of life fortnightly, monthly and/or quarterly (either in clinic or remotely) and report their level of pain on alternate days (remotely).

Start Date01 Sep 2026

Sponsor / Collaborator

Tufts Medical Center, Inc.

100 Clinical Results associated with Upadacitinib hemihydrate

100 Translational Medicine associated with Upadacitinib hemihydrate

100 Patents (Medical) associated with Upadacitinib hemihydrate

1,852

Literatures (Medical) associated with Upadacitinib hemihydrate

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 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 ; Li, Sitong ; Chen, Xiang ; 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

Distinct ocular safety profiles of dupilumab and upadacitinib in atopic dermatitis: a real-world study with ophthalmological and microbiological assessment

Article

Author: Pastuszczak, Maciej ; Stepinska, Paulina ; Zawadzinska-Halat, Kamila

BACKGROUND:

Dupilumab is highly effective in atopic dermatitis (AD) but is associated with ocular surface disease, whereas Janus kinase (JAK) inhibitors may have a more favorable ocular safety profile.

OBJECTIVES:

To compare ocular outcomes and conjunctival microbiology in patients with moderate-to-severe AD treated with dupilumab versus upadacitinib.

METHODS:

In this prospective real-world study, adult patients were treated with dupilumab or upadacitinib and evaluated at baseline and after 16 weeks. Ocular assessment included the Ocular Surface Disease Index (OSDI) and Schirmer test. Conjunctival swabs were collected for culture. Dermatological outcomes were assessed using EASI and DLQI.

RESULTS:

Ninety-six patients were included (upadacitinib, n = 52; dupilumab, n = 44). Both treatments significantly improved EASI and DLQI. Conjunctivitis occurred in 39.0% of dupilumab-treated patients and in none of the upadacitinib-treated patients (p < .001). OSDI improved with upadacitinib (-8.3) but worsened with dupilumab (+2.1) (p < .001). Schirmer test results and bacterial colonization did not differ between groups.

CONCLUSIONS:

Dupilumab and upadacitinib showed comparable dermatological efficacy but distinct ocular safety profiles. Dupilumab was associated with more frequent conjunctivitis and worsening ocular symptoms.

560

News (Medical) associated with Upadacitinib hemihydrate

11 Aug 2026

·www.fiercepharma.com

Biopharma saw a Q2 sales boom led by Lilly, Sanofi, Regeneron and Astellas

With all the fretting from the pharmaceutical industry about competition from China, patent protection losses, price reduction initiatives and other government measures with the potential to hit profits, one might think that drugmakers are struggling these days to make a buck. Not so, according to the second quarter financial results. During the period, nine of the industry’s top 25 drugmakers accomplished year-over-year double-digit revenue increases. The lone company in the top 25 that saw a sales decrease was Teva and that came in at less than 1%. The revenue boom was even more pronounced when comparing figures between the first and second quarters. Of the top 25 drugmakers, more than half (13) realized double-digit sequential gains and only one, Daiichi Sankyo, saw a decline, at 2%. While biopharma companies typically expect sales to increase from the first to the second quarter, double-digit gains are not the norm. From the first to second quarter of 2025, for example, there were five companies that achieved double-digit sequential increases to go along with three drugmakers in decline. In 2024, six companies had double-digit sequential increases from Q1 to Q2, while three saw a decrease. With sales booming in 2026's Q2, 16 of the top 25 companies raised their 2026 guidance. Some of the increases were particularly notable, including a $2.75 billion increase at the midpoint from Bristol Myers Squibb, which credited the boost to surprisingly robust sales of Eliquis. BMS now expects resales from the aging blood thinner to increase by between 20% and 25%, versus a previous expectation of 10% to 15%. Eli Lilly raised the midpoint of its guidance by $2.5 billion, which was no surprise as quarterly increases in projected revenue have been standard practice for the Indianapolis drugmaker thanks to staggering sales of its tirzepatide products. After the first quarter, for example, Lilly hiked its annual projection by $2 billion at the midpoint. In 2025, the company opened the year projecting sales of between $58 and $61 billion before closing the year with a haul of $65 billion. Providing the biggest guidance double-take, however, was Novo Nordisk. After projecting three months earlier that its revenue would decline by between 4% and 12% this year, the Danish company adjusted its projection to a 0% to 6% decline window. Much of the catalyst for the upgrade is the company’s promising launch of its oral version of obesity drug Wegovy, which generated sales of 3.22 billion Danish kroner ($497 million) in the second quarter. Nine years after it first reached the market, meanwhile, Dupixent is getting its second wind as an anti-inflammatory powerhouse—and its co-developers are enjoying the ride. Sanofi and Regeneron achieved year-over-year revenue increases of 16% and 17%, respectively, in the second quarter. The companies' sales were up sequentially by 10% and 19%, respectively. This marked the largest quarterly gain for Sanofi since Q2 of 2022, when its sales spike also was largely attributed to Dupixent. The key to Dupixent’s rejuvenation has come in the form of label expansions over the last two years to treat diseases such as chronic obstructive pulmonary disease (COPD), chronic spontaneous urticaria (CSU), bullous pemphigoid (BP) and allergic fungal rhinosinusitis (AFRS). In the fourth quarter of 2024, Dupixent’s growth had shrunk to 15%. But approaching two years on, sales have increased significantly. In the second quarter of this year, Sanofi reported worldwide revenue from Dupixent up 38% year over year, reaching 5.2 billion euros ($6 billion) for the period. With the results, Sanofi boosted its projection for the IL-4/IL-13 inhibitor to achieve sales of 25 billion euros in 2030. That date looms large as it is the last year that Sanofi and Regeneron are expected to hold patent protection for Dupixent. During the company's recent earnings call, however, Sanofi’s legal chief Roy Papatheodorou said that the company expects extend its exclusivity rights beyond 2031. For its part, Eli Lilly had another quarter of outsized growth at 48%, despite some unexpected struggles in the launch of its oral obesity drug Foundayo. Lilly reported sales of the GLP-1 pill at $98 million in the period, lagging well behind those of Novo Nordisk’s rival weight-loss pill Wegovy, which had a three-month, first-to-market advantage. Nevertheless, Lilly topped the industry rankings for the seventh straight quarter and did it with ease over second-place Astellas (+27%). During its recent metabolic medicine run, Lilly has achieved quarterly year-over-year sales of at least 38% in each period, carried by the success of its tirzepatide products. In Q2, Lilly reported worldwide sales of Mounjaro at $9.9 billion, which were up 91%, and Zepbound at $4.9 billion, good for a 46% year-over-year increase. Helping explain the disparity in sales between the two is that outside the U.S., Mounjaro is the brand name for the medication's use in both Type 2 diabetes and obesity. Meanwhile, Lilly continued to put distance between itself and Novo in the sales of their injected diabetes and obesity products. Novo reported quarterly sales of Ozempic for diabetes at around 31.4 billion Danish kroner ($4.8 billion), which were down 6%, and injected Wegovy at 19.5 billion Danish kroner ($3.0 billion), which were up 3%. Meanwhile, three of the nine companies that pulled off double-digit revenue increases in the quarter are based in Japan. This is nothing new for Astellas, which achieved a 27% sales boost in the period, signaling the ninth time in the last 10 quarters that the company has delivered double digit growth. Those days are likely to end soon, however, as Astellas is expected to lose patent protection in the U.S. next year for prostate cancer treatment Xtandi, which accounted for sales of 277 billion Japanese yen ($1.7 billion) in the quarter, up 19% and accounting (PDF) for 43% of Astellas’ revenue. Daiichi Sankyo achieved a 21% revenue increase in the quarter, which also has been commonplace for the Tokyo-based drugmaker, as it has seen double-digit growth in each of the last four years on the success of its ADC blockbuster Enhertu. During its quarterly presentation earlier this year, Daiichi unveiled a 5-year plan to become one of the top five oncology companies in the industry, establishing a goal to reach sales of 3 trillion yen ($19.1 billion) in 2030, up from 2.1 trillion yen ($13.2 billion) in its 2025 fiscal year. After stagnant sales in 2025, Takeda has regained its footing too as it posted a 10% revenue increase in the most recent period. The last time the company achieved double-digit growth was in the second quarter of FY 2024. After bearing the brunt of the loss of patent protection for ADHD drug Vyvanse last year, Takeda is back in growth mode thanks to its top-selling product Entyvio and a clutch of new drugs, including Fruzaqla, Livtencity and newly approved narcolepsy treatment Orzeyful. With a 10% boost in Q2, AbbVie had its third straight quarter of double-digit growth. The last time the Illinois company put three double-digit quarters together was in 2021, when its immunology superstar Humira was in its prime. After four straight quarters of sales declines in 2023 as Humira faced biosimilar competition, AbbVie has recovered behind Skyrizi and Rinvoq. In the second quarter, Skyrizi achieved a landmark, generating sales of $5.55 billion and prompting the company to increase its revenue projection for Skyrizi to $21.7 billion for this year. The figure would top the $21.2 billion sales high achieved by Humira in 2022, which was the megablockbuster's last full year of patent protection in the U.S. Boehringer Ingelheim accomplished a 12% revenue increase for the first half of 2026, fueled largely by an increase in U.S. demand for Type 2 diabetes and heart failure medicine Jardiance. Also realizing a 12% increase in Q2 was Vertex, which has pulled off double-digit growth in four of the last five quarters thanks to its cystic fibrosis franchise. The company is anxious to expand its rare disease portfolio, however, as evidenced by its largest-ever acquisition last month of Crinetics Pharmaceuticals for $10 billion. Other drugmakers likely poised to join the double-digit revenue club in the third quarter are Amgen, Gilead, Johnson & Johnson and Bristol Myers Squibb. The U.S. companies had respective sales increases of 9%, 8%, 7% and 6% in the second quarter, and each company also raised their 2026 sales guidance.

31 Jul 2026

·www.fiercepharma.com

AbbVie's Skyrizi shrugs off new competition as it thrives in growing psoriasis market

Since they were approved four months apart in 2019, AbbVie’s Skyrizi and Rinvoq have been joined at the hip, central to the Illinois drugmaker's hopes that the duo could replace aging immunology superstar Humira, then the world’s best-selling prescription drug. Seven years later, Skyrizi has proven to be an adequate replacement all by itself. In the second quarter, the IL-23 inhibitor generated sales of $5.55 billion, which were a virtual match for the most ever achieved by Humira in a single quarter. The result was a 24% increase for Skyrizi both sequentially and year over year. AbbVie has increased its revenue projection for Skyrizi to $21.7 billion for this year, which would top the $21.2 billion high achieved by Humira in 2022, which was its last full year of patent protection in the U.S. Skyrizi has continued to thrive in the face of formidable immunology competition, particularly from Johnson & Johnson’s rapidly growing Tremfya, which produced sales of $2 billion in the second quarter, which were up 72% year over year. The newest J&J entrant into the market is highly touted Icotyde, a daily pill for plaque psoriasis which was approved in March of this year. The IL-23 peptide, which was acquired from Protagonist Therapeutics, has drawn a $7.5 billion peak sales projection for the U.S. across all potential indications, according to analysts at Jefferies. “We’ve not seen a material change in our momentum since the launch of Ico,” AbbVie chief commercial officer Jeffrey Stewart said on a conference call Friday. “The vast majority of Ico share that we see is being sourced from the two other orals in the marketplace, which is pretty similar to what we had expected.” Those other two orals are Amgen’s Otezla and Bristol Myers Squibb’s Sotyktu. Stewart also said that New-to-Brand prescription data shows that both new starts and switching starts to Skyrizi have “actually grown” since the launch of Icotyde. The data show that Skyrizi is attracting four times as many new patients as any other biologic or oral treatment in the indication in the U.S., per the executive. “Another point that is probably accurate, as we continue to monitor, is there’s still significant headroom in the moderate-to-severe psoriatic space,” Stewart added. “A large percentage of patients in the United States and around the world are still not on an advanced therapy.” Apart from plaque psoriasis, Skyrizi is also greenlit to treat psoriatic arthritis, Crohn's disease and ulcerative colitis. For its part, Rinvoq’s sales came in at $2.52 billion in the second quarter, good for a 25% year-over-year increase. With Humira adding $756 million, AbbVie’s immunology portfolio produced $8.8 billion in sales, accounting for 52% of the company’s revenue, which totaled $17 billion for the period. The figure was a 10% year-over-year increase and the most generated in a quarter by the company since it split from Abbott in 2013. With the result, AbbVie increased its revenue projection for the year by $300 million. It was the second time this year that the company has upped its 2026 projection by $300 million. The new uptick reflects a $100 increase in the company’s estimate for Skyrizi sales. The company expects another $100 million in additional neuroscience revenues sparked by increased sales of antipsychotic Vraylar and therapeutic Botox, both of which are expected to top $4 billion in sales this year. Another $100 million has been tacked onto the company’s projected combined sales of Rinvoq and blood cancer drug Venclexta.

Drug ApprovalAcquisitionBiosimilarClinical ResultIPO

31 Jul 2026

·www.prnewswire.com

AbbVie Reports Second-Quarter 2026 Financial Results

Reports Second-Quarter Diluted EPS of $2.03 on a GAAP Basis, an Increase of 290.4 Percent; Adjusted Diluted EPS of $3.65, an Increase of 22.9 Percent; These Results Include an Unfavorable Impact of $0.17 Per Share Related to Acquired IPR&D and Milestones Expense Delivers Second-Quarter Net Revenues of $16.990 Billion, an Increase of 10.2 Percent on a Reported Basis or 9.5 Percent on an Operational Basis Second-Quarter Global Net Revenues from the Immunology Portfolio Were $8.786 Billion, an Increase of 15.1 Percent on a Reported Basis, or 14.6 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $5.505 Billion; Global Rinvoq Net Revenues Were $2.525 Billion; Global Humira Net Revenues Were $756 Million Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $3.228 Billion, an Increase of 20.3 Percent on a Reported Basis, or 19.8 Percent on an Operational Basis; Global Vraylar Net Revenues Were $1.071 Billion; Global Botox Therapeutic Net Revenues Were $1.042 Billion; Combined Global Ubrelvy and Qulipta Net Revenues Were $742 Million; Global Vyalev Net Revenues Were $256 Million Second-Quarter Global Net Revenues from the Oncology Portfolio Were $1.650 Billion, a Decrease of 1.5 Percent on a Reported Basis, or 2.4 Percent on an Operational Basis; Global Venclexta Net Revenues Were $771 Million; Global Imbruvica Net Revenues Were $532 Million; Global Elahere Net Revenues Were $211 Million Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.282 Billion, an Increase of 0.3 Percent on a Reported Basis, or a Decrease of 0.9 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $728 Million; Global Juvederm Net Revenues Were $245 Million Announced Definitive Agreement to Acquire Apogee Therapeutics, Deepening AbbVie's Immunology Portfolio Updates 2026 Adjusted Diluted EPS Guidance Range from $13.91 - $14.11 to $13.87 - $14.07; Now Includes a $0.14 per Share Dilutive Impact Related to the Proposed Acquisition of Apogee Therapeutics, Which is Anticipated to Close in the Third Quarter of 2026; Includes an Unfavorable Impact of $0.58 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2026 NORTH CHICAGO, Ill., July 31, 2026 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2026. "AbbVie delivered another excellent quarter, marked by outstanding execution and pipeline advancement. We also announced the proposed acquisition of Apogee Therapeutics, which strengthens our ability to deliver innovative medicines to patients, bolsters our immunology leadership and creates significant shareholder value," said Robert A. Michael, chairman and chief executive officer, AbbVie. "Based on our substantial momentum, AbbVie's long-term outlook remains very strong." Second-Quarter Results Worldwide net revenues were $16.990 billion, an increase of 10.2 percent on a reported basis, or 9.5 percent on an operational basis. Global net revenues from the immunology portfolio were $8.786 billion, an increase of 15.1 percent on a reported basis, or 14.6 percent on an operational basis. Global Skyrizi net revenues were $5.505 billion, an increase of 24.4 percent on a reported basis, or 24.0 percent on an operational basis. Global Rinvoq net revenues were $2.525 billion, an increase of 24.5 percent on a reported basis, or 23.7 percent on an operational basis. Global Humira net revenues were $756 million, a decrease of 35.9 percent on a reported basis, or 36.1 percent on an operational basis. Global net revenues from the neuroscience portfolio were $3.228 billion, an increase of 20.3 percent on a reported basis, or 19.8 percent on an operational basis. Global Vraylar net revenues were $1.071 billion, an increase of 18.9 percent. Global Botox Therapeutic net revenues were $1.042 billion, an increase of 12.2 percent on a reported basis, or 11.6 percent on an operational basis. Global Ubrelvy net revenues were $392 million, an increase of 16.0 percent on a reported basis, or 15.9 percent on an operational basis. Global Qulipta net revenues were $350 million, an increase of 30.9 percent on a reported basis, or 30.3 percent on an operational basis. Global Vyalev net revenues were $256 million. Global net revenues from the oncology portfolio were $1.650 billion, a decrease of 1.5 percent on a reported basis, or 2.4 percent on an operational basis. Global Venclexta net revenues were $771 million, an increase of 11.6 percent on a reported basis, or 9.6 percent on an operational basis. Global Imbruvica net revenues were $532 million, a decrease of 29.4 percent. Global Elahere net revenues were $211 million, an increase of 33.1 percent on a reported basis, or 31.8 percent on an operational basis. Global net revenues from the aesthetics portfolio were $1.282 billion, an increase of 0.3 percent on a reported basis, or a decrease of 0.9 percent on an operational basis. Global Botox Cosmetic net revenues were $728 million, an increase of 5.2 percent on a reported basis, or 3.4 percent on an operational basis. Global Juvederm net revenues were $245 million, a decrease of 6.0 percent on a reported basis, or 6.6 percent on an operational basis. On a GAAP basis, the gross margin ratio in the second quarter was 74.7 percent. The adjusted gross margin ratio was 84.7 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 21.4 percent of net revenues. The adjusted SG&A expense was 21.0 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 13.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues. Acquired IPR&D and milestones expense was 1.7 percent of net revenues. On a GAAP basis, the operating margin ratio in the second quarter was 37.9 percent. The adjusted operating margin ratio was 48.3 percent. Net interest expense was $679 million. On a GAAP basis, the tax rate in the quarter was 15.5 percent. The adjusted tax rate was 14.7 percent. Diluted earnings per share (EPS) in the second quarter was $2.03 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $3.65. These results include an unfavorable impact of $0.17 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie and Apogee Therapeutics announced a definitive agreement under which AbbVie will acquire Apogee and its diverse pipeline of clinical-stage candidates in development across inflammatory and immunological diseases. The proposed acquisition includes zumilokibart (APG777), a late-stage, half-life extended monoclonal antibody targeting IL-13 for atopic dermatitis (AD), as well as APG273, a potential best-in-category long-acting combination targeting IL-13 and thymic stromal lymphopoietin (TSLP) in asthma. The acquisition holds potential for substantial shareholder value creation, with mega-blockbuster peak sales potential across Apogee's pipeline of assets, and is expected to close in the third quarter of 2026. The transaction values Apogee at a total equity value of approximately $10.9 billion. Additional information on the transaction can be found at investors.abbvie.com. AbbVie announced the U.S. Food and Drug Administration (FDA) and the European Commission (EC) approved Skyrizi (risankizumab) for the treatment of children six years of age and older with moderate to severe plaque psoriasis. The FDA also approved Skyrizi for pediatric use in psoriatic arthritis. These approvals were supported by data from Phase 3 OptIMMize clinical trial program. AbbVie announced the EC approved Rinvoq (upadacitinib) for the treatment of adult and adolescent patients with non-segmental vitiligo. With this approval, Rinvoq is the first systemic medication approved in the European Union (EU) for patients with non-segmental vitiligo. This approval is supported by data from the Phase 3 Viti-Up clinical program, in which Rinvoq met both co-primary endpoints, with statistically significant and clinically meaningful improvements in total body and facial repigmentation at week 48, as well as key ranked secondary endpoints. AbbVie announced the EC approved Rinvoq for the treatment of adult and adolescent patients with severe alopecia areata. This approval is supported by data from the Phase 3 UP-AA clinical program, in which Rinvoq met the primary endpoint of severity of alopecia tool score ≤ 20 as well as key secondary endpoints, including improvements in eyebrows and eyelashes, at week 24. At the 2026 Digestive Disease Week (DDW) Annual Meeting, AbbVie presented new data across its gastroenterology portfolio, including 18 abstracts in Crohn's disease (CD) and ulcerative colitis (UC). Presentations included real-world evidence and long-term findings that reinforced the efficacy, safety profile and durability of Skyrizi and Rinvoq in inflammatory bowel diseases (IBD). AbbVie announced the EC approved Aquipta (atogepant) for the acute treatment of migraine in adults with or without aura. This approval marks the second indication for Aquipta in the EU, where it is now approved as both an acute treatment option for migraine attacks and as a preventive treatment option for adults with chronic or episodic migraine who experience at least four migraine days per month. The approval is supported by data from the Phase 3 ECLIPSE trial, which showed that Aquipta resulted in statistically significant pain freedom at two hours versus placebo during the first migraine attack, with sustained pain freedom from 2 to 48 hours and a clinically meaningful and consistent effect across multiple migraine attacks. AbbVie announced the FDA approved Decnupaz (pivekimab sunirine) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare and aggressive hematologic malignancy. Decnupaz is the first antibody-drug conjugate (ADC) approved for BPDCN that is initiated in an outpatient setting and marks AbbVie's first ADC approved for blood cancer. The approval is supported by data from the Phase 1/2 CADENZA trial, in which newly diagnosed patients with BPDCN treated with Decnupaz demonstrated clinically meaningful and durable responses. AbbVie announced the EC authorized an expanded label for Venclyxto (venetoclax) to include use in combination with acalabrutinib and use in combination with Imbruvica (ibrutinib) for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The authorization provides an all-oral, fixed-duration, chemotherapy-free treatment option for patients with CLL and supports the potential for time off treatment. The expanded label is supported by data from the Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trial. AbbVie announced the EC granted marketing authorization for Tepkinly (epcoritamab) in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, in which fixed-duration Tepkinly plus R2 achieved statistically significant improvement of progression-free survival (PFS) and overall response rates (ORR) compared to R2, with approximately three out of four patients achieving a complete response (CR). This approval marks the first bispecific-based therapy approved in Europe for the treatment of R/R FL in the second-line setting, offering patients a chemotherapy-free option. Tepkinly/Epkinly is being co-developed by AbbVie and Genmab. AbbVie announced topline results from the Phase 3 EPCORE DLBCL-4 trial evaluating the combination of Epkinly (epcoritamab) and lenalidomide, compared to rituximab plus gemcitabine plus oxaliplatin in adult patients with R/R diffuse large B-cell lymphoma (DLBCL) who received at least one prior line of therapy. In the trial, the chemotherapy-free combination of Epkinly plus lenalidomide demonstrated statistically significant and clinically meaningful improvement in PFS. The safety profile of Epkinly when administered in combination with lenalidomide was consistent with the known safety profiles of the individual agents. At the American Society of Clinical Oncology (ASCO) Annual Meeting, AbbVie announced new data demonstrating the breadth and momentum of its next-generation oncology pipeline. Presentations highlighted the potential of AbbVie's novel topoisomerase 1 inhibitor–based ADC and T‑cell engager platforms within solid tumors and blood cancers, including oral presentations in prostate cancer, small cell lung cancer (SCLC), platinum-resistant ovarian cancer (PROC) and multiple myeloma (MM). At the European Hematology Association (EHA) 2026 Congress, AbbVie presented data that reinforced its leadership and commitment to ongoing research to improve outcomes for people living with blood cancers. Featured data from AbbVie's blood cancer portfolio and pipeline included 21 oral and poster presentations, which highlighted etentamig (ABBV-383), Epkinly and Decnupaz. The presentations also showcased Venclexta (venetoclax) data, including a final analysis of the Phase 3 CLL14 trial which demonstrated that after a median follow-up of 9.2 years, treatment with Venclexta plus obinutuzumab resulted in superior PFS compared to treatment with obinutuzumab plus chlorambucil in previously untreated CLL. Allergan Aesthetics announced the FDA approved Skinvive by Juvederm as the first hyaluronic acid injectable indicated to reduce neck lines for the improvement of neck appearance in adults over the age of 21. This approval is supported by a randomized, multicenter, evaluator-blinded, controlled pivotal clinical study in which participants treated with Skinvive by Juvederm saw a clinically significant improvement in neck lines at one month. This approval represents the second FDA-approved indication for Skinvive by Juvederm, which is also approved to improve skin smoothness of the cheeks in adults. Allergan Aesthetics announced the EC and Health Canada approved Boey (trenibotulinumtoxinE) as the first rapid-onset, short-duration neurotoxin for the temporary improvement of moderate to severe glabellar lines in adults. These approvals are supported by data from two Phase 3 clinical trials, in which Boey demonstrated rapid onset of action as early as eight hours after administration and observed efficacy duration of two to three weeks, with treatment-emergent adverse events similar to placebo. AbbVie announced the EC approved Maviret (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C virus (HCV) infection in adults and children aged 3 years and older. This approval gives clinicians an option to initiate treatment as soon as acute infection is confirmed and makes Maviret the only treatment approved in the EU for both acute and chronic HCV infection. Full-Year 2026 Outlook AbbVie is updating its adjusted diluted EPS guidance to include the impact of the proposed Apogee Therapeutics acquisition, which is expected to be $0.14 dilutive in 2026, based upon an anticipated close in the third quarter of this year. This dilution is partially offset by $0.10 of overperformance. As a result, AbbVie is updating its adjusted diluted EPS guidance range for the full year 2026 from $13.91 - $14.11 to $13.87 - $14.07, reflecting a change of $0.04 at the midpoint. The company's 2026 adjusted diluted EPS guidance includes an unfavorable impact of $0.58 per share related to acquired IPR&D and milestones expense incurred year-to-date through the second quarter 2026. This guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the second quarter of 2026, as both cannot be reliably forecasted. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our second-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2026 and 2025 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with generally accepted accounting principles in the United States (GAAP) and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks related to the proposed acquisition of Apogee Therapeutics, Inc. ("Apogee"), including the possibility that such acquisition may not be consummated on the anticipated timeframe or at all, risks related to the ability to realize the anticipated benefits of the proposed acquisition on the anticipated timeframe or at all, risks that the costs to consummate the acquisition or to obtain the anticipated benefits of the proposed acquisition could be greater than expected, the failure to obtain applicable regulatory or Apogee stockholder approval in a timely manner or otherwise, the risk that an event occurs that could give rise to the right of AbbVie or Apogee to terminate the merger agreement, risks related to the ability of AbbVie and Apogee to successfully integrate the businesses and the possibility that such integration may be more difficult, time consuming or costly than expected, risks that the proposed acquisition disrupts Apogee's or AbbVie's current plans and operations and makes it more difficult to maintain business and operational relationships, the diversion of management's attention from ongoing business operations and opportunities due to the proposed transaction, negative effects of the consummation of the proposed acquisition on business or employee relationships or the market price of AbbVie's common stock and/or operating results, significant transaction costs, the assumption of unknown liabilities, the risk of litigation and/or regulatory actions related to the proposed acquisition, the risk that zumilokibart (APG777) or other Apogee pipeline assets may not demonstrate the anticipated success, safety, or efficacy in ongoing or future clinical trials, the risk that positive interim clinical trial results for zumilokibart (APG777) may not be predictive of results in later-stage or larger clinical trials, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to AbbVie's industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes, tariffs and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's and Apogee's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information; and Item 1A, "Risk Factors," of Apogee's most recently filed Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and in other documents that Apogee subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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Clinical ResultDrug ApprovalPhase 3AcquisitionFinancial Statement

100 Deals associated with Upadacitinib hemihydrate

External Link

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
Alopecia Areata	European Union	AbbVie, Inc.	29 Jul 2026
Alopecia Areata	Iceland	AbbVie, Inc.	29 Jul 2026
Alopecia Areata	Liechtenstein	AbbVie, Inc.	29 Jul 2026
Alopecia Areata	Norway	AbbVie, Inc.	29 Jul 2026
Nonsegmental vitiligo	European Union	AbbVie, Inc.	29 Jun 2026
Nonsegmental vitiligo	Iceland	AbbVie, Inc.	29 Jun 2026
Nonsegmental vitiligo	Liechtenstein	AbbVie, Inc.	29 Jun 2026
Nonsegmental vitiligo	Norway	AbbVie, Inc.	29 Jun 2026
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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pediatric Crohn's Disease	Phase 3	United States	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	China	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Japan	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Australia	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Belgium	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Brazil	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Bulgaria	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Canada	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	France	AbbVie, Inc.	08 Aug 2024
Pediatric Crohn's Disease	Phase 3	Greece	AbbVie, Inc.	08 Aug 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03738397 (Heads Up, Pubmed \| J Dermatolog Treat)	Phase 3	Dermatitis, Atopic	385	Dupilumab	dcysoxqmen(btbxjxphjq) = baxucvzbcf ncxkxfvsjf (pjebcudxzn )	Positive	31 Dec 2026
				Upadacitinib	dcysoxqmen(btbxjxphjq) = pwtdgavbkx ncxkxfvsjf (pjebcudxzn )
NCT02782663 (CELEST OLE, CTgov)	Phase 2	Crohn Disease	107	Upadacitinib (Upadacitinib 30 mg)	bwclteftjm = myvenvrxht dbxkfvpcgf (ewwkrhsqhv, qzytaexzzc - tbnzkespzl) View more	-	13 Aug 2026
				Upadacitinib (Upadacitinib 15 mg, Then 30 mg)	bwclteftjm = cvolpalwjo dbxkfvpcgf (ewwkrhsqhv, iygaxtnhoq - qpoyuudcse) View more
NCT05814627 (SELECT-SWITCH, Pubmed \| Ann Rheum Dis)	Phase 3	Rheumatoid Arthritis	492	Upadacitinib	tkvoowftqp(ifuntgwfba) = mpnchnodwd ybaroqbzfz (jygdrktzah ) View more	Positive	01 Jul 2026
				Adalimumab	tkvoowftqp(ifuntgwfba) = mmrvnccfph ybaroqbzfz (jygdrktzah ) View more
NCT03569293 \| NCT03607422 (Measure Up 1, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Dermatitis, Atopic	398	Upadacitinib 15 mg	zihlzhdbhh(iqkqdoqukc) = nephodxzck havqukrzdx (kagzzsgfwu ) View more	Positive	01 Jul 2026
				Upadacitinib 30 mg	zihlzhdbhh(iqkqdoqukc) = qukabvjkmi havqukrzdx (kagzzsgfwu ) View more
EULAR2026	Not Applicable	Arthritis, Psoriatic \| Rheumatoid Arthritis \| Ankylosing Spondylitis	185	Tofacitinib	kfgzekdvbu(adgswlcaub) = Transient abdominal pain and other gastrointestinal symptoms were most frequent adverse event in all agents. kcvsswkdnu (gckmvbsogu ) View more	Positive	11 Jun 2026
				Upadacitinib
EULAR2026	Not Applicable	Dermatomyositis	40	Upadacitinib (dermatomyositis)	khzebcunrl(zgyiwpkdsu) = iqnvyolxzp stoglromqt (qvsnmdwiqb, 10.35) View more	Positive	11 Jun 2026
SELECT-GCA (EULAR2026)	Phase 3	Giant Cell Arteritis	-	UPA15 (new-onset or relapsing GCA)	qnjcmaekub(ysbnhhhmyk) = No MACE occurred with UPA15, while 2 were reported with PBO, both in the new-onset subgroup. ebwxyklmqo (ktocbzegrd ) View more	Positive	11 Jun 2026
				Placebo (new-onset or relapsing GCA)
EULAR2026	Not Applicable	Rheumatoid Arthritis	454	Upadacitinib	ftcywqmyol(uqekkafuez): RR = 1.3 (95.0% CI, 0.77 - 2.19) View more	Similar	11 Jun 2026
				Tocilizumab
EULAR2026	Not Applicable	Giant Cell Arteritis	47	Secukinumab	xyrxifilmr(hdvlvlixea) = sjvdbrodja iirfcbgdjg (iwagwungke ) View more	Positive	11 Jun 2026
				Jak inhibitors	ddzhoveqhn(sczqzztevx) = nygnydwrsz pcyacgamnu (xndzkgurac ) View more
UPtimum (EULAR2026)	Not Applicable	Arthritis, Psoriatic	460	Upadacitinib (MONO)	jmqluoeacs(ivtbradssj) = dfpibpfhus golbkudyns (qzydstmpjc, 42.5 - 52.7) View more	Positive	11 Jun 2026
				Upadacitinib+methotrexate (COMBO)	jmqluoeacs(ivtbradssj) = vlptkwfbxb golbkudyns (qzydstmpjc, 47.4 - 67.0)

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