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

240

Clinical Trials associated with Upadacitinib hemihydrate

NCT07896434

/ Not yet recruitingPhase 3

A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, and Tolerability of Upadacitinib in Pediatric Subjects 6 to <12 Years Old With Non-Segmental Vitiligo Who Are Eligible for Systemic Therapy

Vitiligo is a common, long-lasting disease that happens when the immune system attacks melanocytes (skin cells that produce the skin-coloring pigment melanin) in the skin leading to loss of color. Non-segmental vitiligo (NSV) occurs when patches of color loss appear on both sides of the body, such as both knees or both hands. This study is to evaluate how effective, safe and tolerable upadacitinib is for the treatment of non-segmental vitiligo in pediatric participants ages 6 to 11 years old.
This study will have two periods: Period A and Period B. In Period A, participants are placed in 1 of 2 groups called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will receive placebo. Participants who complete Period A will continue into Period B and remain on blinded treatment.
In Studies 1 and 2: Period A, participants will receive oral tablets (or oral solution) of upadacitinib or placebo once a day for 48 weeks. In Period B,participants who complete Period A will continue into Period B and remain on blinded treatment for 112 weeks. Participants will be followed up for 30 days. This study will enroll approximately 154 pediatric participants at 110 sites worldwide.
There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Start Date28 Jan 2027

Sponsor / Collaborator

AbbVie, Inc.

NCT07904754

/ Not yet recruitingPhase 2

A Phase 2b, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderately to Severely Active Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic inflammatory disease that primarily affects the joints, causing pain, swelling, stiffness, and loss of function. Synovial fibroblasts play a key role in RA pathogenesis, with treatment-refractory patients demonstrating increased numbers of these cells. The goal of this study is to evaluate the safety and effectiveness of ABBV-2294 (a combination of ABBV-722 and upadacitinib) compared to each drug alone in treating moderately to severely active RA. The platform study will measure improvements in disease activity using the American College of Rheumatology (ACR) criteria, changes in disease activity scores, and quality of life measures.
ABBV-2294 is an investigational combination drug being developed for the treatment of moderately to severely active rheumatoid arthritis. This is a Phase 2b, randomized, double-blind platform study. In sub-study 1, participants are placed in 1 of 5 groups, called treatment arms. Each group receives a different treatment consisting of either ABBV-722 alone, upadacitinib alone, or various doses of ABBV-722 combined with upadacitinib. Adult participants with a diagnosis of moderately to severely active rheumatoid arthritis who have failed at least 1 prior biologic disease-modifying antirheumatic drug (bDMARD) will be enrolled. Around 250 participants will be enrolled in the study at multiple sites worldwide.
Participants will receive oral tablet doses of ABBV-2294 (combination of ABBV-722 and upadacitinib), ABBV-722 alone, or upadacitinib alone. The study comprises a 24-week Double-Blind Phase (Period 1) followed by an optional 52-week Blinded Long Term Extension Phase (Period 2), for a total treatment duration of up to 76 weeks. After completing treatment, participants will have a 30-day Follow-Up Period.
Participants will attend regular visits during the study at a hospital or clinic, including screening, baseline, and scheduled visits through Week 76, followed by a follow-up visit. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

Start Date07 Dec 2026

Sponsor / Collaborator

AbbVie, Inc.

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

100 Clinical Results associated with Upadacitinib hemihydrate

100 Translational Medicine associated with Upadacitinib hemihydrate

100 Patents (Medical) associated with Upadacitinib hemihydrate

2,141

Literatures (Medical) associated with Upadacitinib hemihydrate

01 Mar 2027·BIOMATERIALS

Upadacitinib and shikonin co-loaded nanodrug for rheumatoid arthritis therapy via attenuating inflammation and protecting cartilage

Article

Author: Cai, Xiong ; Liu, Bin ; Yan, Ping ; Tang, Yuanyuan ; Lin, Ye ; Liu, Longji ; Liu, Liang ; Li, Mengyan ; Yang, Mengxue

Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by persistent inflammation, excessive oxidative stress, and progressive joint destruction. Although upadacitinib (UP) monotherapy exhibits robust anti-inflammatory efficacy, its systemic administration is limited by a narrow target profile and hepatotoxicity. To address these challenges, we rationally designed a biomimetic nanodrug (HA-M@SHK-Fe@BSA-UP NPs) co-delivering UP with shikonin (SHK), a natural naphthoquinone with antioxidant activity and hepatoprotective effects. This nanoplatform self-assembled via iron-mediated metal-phenolic coordination, using bovine serum albumin (BSA) as a bridge, with a dual-surface modification of erythrocyte/macrophage hybrid membrane (M) and hyaluronic acid (HA). This architecture enabled prolonged circulation and pH-responsive drug release. In vitro, the nanodrug exhibited efficient reactive oxygen species (ROS) scavenging and targeted cellular uptake. Mechanistically, the nanodrug acted on macrophages and primary rat knee-joint chondrocytes (PRKCs) in parallel. It effectively drove M1-to-M2 polarization at least in part through the JAK1/STAT3/PKM2 axis and directly restored the function of PRKCs to suppress matrix degradation. In vivo, Ce6-based fluorescence imaging showed that the nanodrug accumulated 4.55-fold more in arthritic joints than free Ce6. Moreover, this nanodrug significantly suppressed inflammation at a low dosage and promoted cartilage and bone repair in AIA and CIA rat models, while showing reduced signs of liver injury. In summary, this self-assembled nanodrug offers a promising strategy for inflammatory disease treatment.

01 Mar 2027·JOINT BONE SPINE

Infection risk associated with steroid-sparing therapies in GCA, PMR, and ANCA-associated vasculitis: A systematic review

Article

Author: Sudireddy, Divya ; Neogi, Tuhina ; LaValley, Michael ; Leung, Brent ; Liew, Jean W ; Felson, David ; Flynn, David

OBJECTIVE:

Giant cell arteritis (GCA), polymyalgia rheumatica (PMR), and ANCA-associated vasculitis (AAV) often require prolonged glucocorticoid therapy. Steroid-sparing biologic and small molecule therapies reduce glucocorticoid exposure, but may increase infection risk, particularly in older adults. We evaluated infection risk associated with these therapies with concomitant glucocorticoid treatment, versus glucocorticoid treatment alone, in vasculitis/PMR clinical trials.

METHODS:

We searched PubMed, Embase, Cochrane, and ClinicalTrials.gov using terms related to GCA, PMR, AAV, biologics (tocilizumab, sarilumab), small molecule therapies (upadacitinib, avacopan), glucocorticoids, and infection outcomes. We included randomized controlled trials (RCTs) comparing biologics or small molecules plus glucocorticoid (active intervention) versus glucocorticoid monotherapy (comparator) reporting infection outcomes. We calculated the relative risk (RR) of infection and difference in glucocorticoid dose between the comparator and active intervention groups.

RESULTS:

We included 10 RCTs (1487 patients total, enrolling adults averaged≥50 years): 4 tocilizumab, 3 avacopan, 2 sarilumab, and 1 upadacitinib. When the active intervention had much lower glucocorticoid dosing than the comparator, the RR for infection was either close to 1 or<1. When the active intervention glucocorticoid dose was comparable to the comparator, the RR for infection was>1.

CONCLUSION:

Steroid-sparing therapies reduced glucocorticoid exposure with varying magnitudes but were not consistently associated with lower infection risk. These findings underscore the heightened risk of infection when these novel therapies are used in combination with glucocorticoids when the glucocorticoid dose cannot be adequately tapered, particularly in older adults.

01 Mar 2027·TISSUE & CELL

Upadacitinib ameliorates joint inflammation and RA-associated muscle atrophy in a murine model in association with JAK-STAT pathway inhibition

Article

Author: Sun, Yafeng ; Hong, ZhiLin ; Shi, Hongying ; Chen, Xiaoqing

OBJECTIVE:

This study investigated the therapeutic effects of upadacitinib (UPA), a Janus kinase (JAK) inhibitor, against muscle atrophy in a murine model of rheumatoid arthritis (RA) induced by mannan, and explored the potential molecular mechanisms involved.

METHODS:

Male SKG/Jcl mice were administered mannan to induce RA and subsequently treated with either a low dose (5 mg/kg/day) or high dose (15 mg/kg/day) of UPA, or served as control or model groups. Grip strength and whole-body lean mass were quantified using an electronic dynamometer and Minispec LF-50 analyzer, respectively. Mitochondrial morphology and muscle fiber ultrastructure were assessed via succinate dehydrogenase (SDH) staining and transmission electron microscopy (TEM). Histopathological joint and muscle damage was evaluated using Hematoxylin and Eosin (HE) staining. Protein expression of myosin heavy chains (MYH7, MYH1), phosphorylated JAK1 (p-JAK1), and phosphorylated STAT3 (p-STAT3) was determined by Western blot and immunofluorescence staining. Serum levels of inflammatory cytokines IL-1β and IL-6 were measured using enzyme-linked immunosorbent assay (ELISA).

RESULTS:

UPA treatment significantly attenuated synovial inflammatory infiltration and joint structural damage in RA mice, accompanied by a reduction in serum IL-1β and IL-6 levels. Functionally, UPA administration improved muscle strength and increased whole-body lean mass. Notably, UPA increased the expression of MYH7 and MYH1, which were reduced in the RA model. Furthermore, UPA treatment was associated with reversal of mitochondrial ultrastructural abnormalities and Z-line thinning. Mechanistically, elevated phosphorylation of JAK1 and STAT3 in skeletal muscle of model mice was markedly inhibited by UPA. The high-dose UPA group exhibited numerically greater improvements in most measured parameters.

CONCLUSION:

Upadacitinib treatment is associated with reversed aberrant muscle fiber type expression and mitochondrial ultrastructural abnormalities, potentially through inhibition of the over-activated JAK-STAT signaling pathway. These findings provide preclinical evidence that UPA may improve muscle-related phenotypes in this experimental model of RA. However, whether these effects are directly mediated by muscle-intrinsic JAK1 inhibition or are secondary to systemic inflammation resolution requires further investigation.

588

News (Medical) associated with Upadacitinib hemihydrate

10 Nov 2026

·www.fiercepharma.com

UCB continues reign as largest drug ad spender as Bimzelx once again tops the ranks

UCB’s immunology drug Bimzelx has topped the pharma drug ad spending charts for the third month in a row. That’s according to the latest data for October’s streaming and linear TV rankings shared with Fierce by iSpot.TV. UCB, which has stormed up the rankings in recent months thanks in part to higher overall spending and iSpot.TV’s new focus on streaming ad dollars, shelled out $66.2 million on Bimzelx ads in October. This put it firmly in first place, with 57.42% of spending going toward streaming and 42.58% toward linear TV. Its nearest rival in second place was Johnson & Johnson’s immunology drug Tremfya, up three spots from its September ranking , with spending hitting $42.1 million, though most of that (76.87%) went toward traditional linear TV. AbbVie’s immunology therapy Skyrizi held steady in third place, with a similar breakdown to J&J. Of its $40.7 million in total spending, most (73.59%) went toward linear TV. AbbVie’s second blockbuster immunology drug, Rinvoq, also held steady in fourth place, with $31.5 million in spending and most of that (more than 80%) going toward linear TV. Eli Lilly’s obesity drug Zepbound jumped four places to reach fifth place in October, while its new oral obesity drug Foundayo fell four spots to sixth place. In an unusual move, AbbVie landed in seventh place with its Botox injection, an unfamiliar sight in these rankings. The company spent $22.9 million in total, split between ads for Botox's migraine and aesthetic indications, including frown lines. Another unusual entrant was Amgen’s autoimmune therapy Uplizna, which was absent from September’s rankings and has rarely appeared on these lists. The drug reached eighth place in October, with $21.7 million in spending and a huge 94.6% of that going toward streaming. Johnson & Johnson’s atypical antipsychotic drug Caplyta fell two spots to ninth, while Sanofi and Regeneron’s megablockbuster immunology drug Dupixent rounded out the top 10 with $17.8 million in total spending after being absent from September’s rankings. Check out the top 10 from iSpot.TV below. Movement : No change What is it? UCB’s immunology drug Est. cross-platform TV ad spend: $66.2 million total (57.42% streaming / 42.58% linear) Hidradenitis Suppurativa: $40.9 million total (65.72% streaming / 34.28% linear) Psoriatic Arthritis: $13 million total (40.15% streaming / 59.85% linear) Psoriasis: $12.3 million total (48.03% streaming / 51.97% linear) Top linear TV network by spend SOV: NBC (25.39%) Top linear TV program by spend SOV: NFL (13.17%) Number of linear spots: Eight (three psoriasis, two Hidradenitis Suppurativa, three psoriatic arthritis) Biggest-ticket ad (by linear TV ad spend): 'I'm Back' (est. $9.7 million) Movement : Up three spots What is it? Johnson & Johnson’s immunology drug Est. cross-platform TV ad spend: $42.1 million total (23.13% streaming / 76.87% linear) UC/Crohn’s Disease: $27.9 million total (14.20% streaming / 85.80% linear) Psoriatic Arthritis: $10.1 million total (25.57% streaming / 74.43% linear) Psoriasis: $4.1 million total (78.43% streaming / 21.57% linear) Top linear TV network by spend SOV: NBC (21.99%) Top linear TV program by spend SOV: NFL (36.73%) Number of linear spots: Six (one psoriasis, two Crohn’s/UC, three psoriatic arthritis). Biggest-ticket ad (by linear TV ad spend): 'Relentless Weed: Running’ (est. $20.8 million) What is it? AbbVie’s immunology therapy Skyrizi Est. cross-platform TV ad spend: $40.7 million total (26.41% streaming / 73.59% linear) Psoriasis: $18.3 million total (30.96% streaming / 69.04% linear) Crohn’s/UC: $16.7 million total (17.67% streaming / 82.33% linear) Psoriatic Arthritis: $5.8 million total (37.28% streaming / 62.72% linear) Top linear TV network by spend SOV: NBC (16.32%) Top linear TV program by spend SOV: NFL (17.85%) Number of linear spots: Seven (three psoriasis, three Crohn’s/UC, one psoriatic arthritis) Biggest-ticket ad (by linear TV ad spend) : ‘Ready for the Moment’ (est. $8.5 million) What is it? AbbVie’s JAK immunology drug Est. cross-platform TV ad spend: $31.5 million total (19.14% streaming / 80.86% linear) UC/Crohn’s: $13.6 million total (17.96% streaming / 82.04% linear) Eczema: $8.8 million total (18.95% streaming / 81.05% linear) Arthritis: $8.5 million total (15.19% streaming / 84.81% linear) AS: $634K total (100.00% streaming) Top linear TV network by spend SOV: NBC (20.84%) Top linear TV program by spend SOV: The Voice (7.00%) Number of linear spots: Four (one arthritis, two eczema, one UC/Crohn's disease) Biggest-ticket ad (by linear TV ad spend): 'Classic Car, Tennis and Fire Station' (est. $11.1 million) Movement: Up four spots What is it? Eli Lilly’s obesity drug Est. cross-platform TV ad spend: $26.9 million total (17.12% streaming / 82.88% linear) Top linear TV network by spend SOV: CBS (28.93%) Top linear TV program by spend SOV: NFL (45.67%) Number of linear spots: Four Biggest-ticket ad (by linear TV ad spend): 'Medicare Open Doors’ (est. $14.1 million) Movement: Down four spots What is it? Eli Lilly’s oral obesity drug Est. cross-platform TV ad spend: $25.3 million total (46.50% streaming / 53.50% linear) Top linear TV network by spend SOV: Fox (25.46%) Top linear TV program by spend SOV: NFL (29.77%) Number of linear spots: Six Biggest-ticket ad (by linear TV ad spend) : 'Weight Management: Martha's House Rules' (est. $9.4 million) Movement: Not listed last month What is it? AbbVie’s aesthetics and medical use injection Est. cross-platform TV ad spend: $22.9 million total (36.56% streaming / 63.44% linear) Migraine: $12 million total (18.75% streaming / 81.25% linear) Cosmetic: $10.9 million total (56.27% streaming / 43.73% linear) Top linear TV network by spend SOV: Fox (9.97%) Top linear TV program by spend SOV: MLB (9.87%) Number of linear spots: Seven (two migraine, five cosmetic) Biggest-ticket ad (by linear TV ad spend): 'Spectator' (est. $5 million) What is it? Amgen’s autoimmune therapy Est. cross-platform TV ad spend: $21.7 million total (94.60% streaming / 5.40% linear) Top linear TV network by spend SOV: CBS (23.67%) Top linear TV program by spend SOV: Survivor (18.47%) Number of linear spots: One Biggest-ticket ad (by linear TV ad spend): 'Plans' (est. $1.2 million) Movement: Down two spots What is it? Johnson & Johnson’s atypical antipsychotic drug Est. cross-platform TV ad spend: $19.1 million total (13.13% streaming / 86.87% linear) MDD: $11.7 million total (6.43% streaming / 93.57% linear) Bipolar: $7.4 million total (23.81% streaming / 76.19% linear) Top linear TV network by spend SOV: NBC (22.79%) Top linear TV program by spend SOV: NFL (16.82%) Number of linear spots: Four (two MDD, two bipolar) Biggest-ticket ad (by linear TV ad spend): 'Missing Out' (est. $5.6 million) What is it? Sanofi and Regeneron’s immunology drug Est. cross-platform TV ad spend: $17.8 million total (24.23% streaming / 75.77% linear) Eczema: $10.2 million total (14.02% streaming / 85.98% linear) Asthma/COPD: $6.6 million total (28.53% streaming / 71.47% linear) Gastrointestinal: $1.1 million total (96.24% streaming / 3.76% linear) Top linear TV network by spend SOV: NBC (34.29%) Top linear TV program by spend SOV: NFL (35.43%) Number of linear spots: Ten (three gastrointestinal, three asthma/COPD, four eczema) Biggest-ticket ad (by linear TV ad spend): 'Volleyball' (est. $4.7 million)

Financial StatementImmunotherapyADC

04 Nov 2026

·www.biospace.com

AbbVie bets up to $1.47B for Nxera’s discarded IBD program

iStock, Shendart AbbVie’s $100 million upfront cash payment will purchase global rights to Nxera’s deprioritized oral small molecule, which has already completed Phase 1 testing. AbbVie is doling out $100 million in cash to gain exclusive licensing rights to Nxera Pharma’s EP4 receptor agonist program in inflammatory bowel disease. Under the terms of the deal, Nxera could collect up to $1.37 billion more in milestone payments, plus tiered royalties, according to a Wednesday release . In exchange, AbbVie will gain access to Nxera’s EP4 agonist program, including global rights to develop and commercialize an oral small molecule called NXE0033744 in inflammatory bowel disease (IBD). IBD is a group of chronic inflammatory conditions impacting the gastrointestinal (GI) tract—primarily ulcerative colitis and Crohn’s disease. Japan-based Nxera, which rebranded from Sosei Heptares in 2024, culled the IBD program as part of a restructuring in November 2025 that also claimed 15% of the company’s workforce in Japan and the U.K. in the name of clearing the company’s “path to profitability.” Discovered using Nxera’s NxWave platform, NXE0033744 is designed to address unmet need for patients with IBD that have not experienced satisfactory disease control. The asset is intended to work locally in the GI tract, reducing systemic exposure. NXE0033744 has already been tested in a Phase 1 trial among a group of patients with ulcerative colitis and in a nonsteroidal anti-inflammatory drug (NSAID) challenge cohort. Layoffs Nxera’s Quest for Profitability Claims 15% of Workforce Nxera, which formerly went by Sosei, will also reprioritize its pipeline to focus on obesity, metabolic and endocrine diseases. November 18, 2025 · 2 min read · Tristan Manalac Read more The AbbVie deal—struck with Nxera’s U.K. subsidiary—builds on an existing alliance between the companies. Two years after penning a 2020 deal in inflammatory and autoimmune diseases worth up to $409 million, AbbVie inked a separate multi-target neuroscience collaboration with the biotech that could eventually total $1.3 billion. Overall, Jefferies analysts view the deal “positively,” according to a Wednesday note. The deal also includes near-term milestones, which Jefferies believes will contribute to Nxera’s 2027 revenue. Also on Wednesday, Nxera raised its full year forecast to the high end of its previous range, now targeting 48.8 billion Yen ($307.9 million) in revenue, with AbbVie’s $100 million upfront payment expected on the biotech’s fourth quarter term sheet. “The upfront payment, together with potential near-term milestone payments, will further strengthen our financial position while enabling Nxera to share in the future success of NXE0033744 and the value it may create,” Nxera CEO Christopher Cargill said in a Wednesday release about the partnership. With the new cash infusion, Jefferies believes Nxera is likely to remain profitable. Earnings AbbVie’s Q3 beat should keep ‘train rolling’ as company eyes bolt-on deals Strong immunology and neuroscience sales fueled AbbVie’s latest quarterly beat as the pharma’s stock continues to hit all-time highs. October 30, 2026 · 3 min read · Gabrielle Masson Read more For AbbVie, the deal gives the immunotherapy giant another IBD candidate to potentially build on the success of Skyrizi and Rinvoq—possibly in combination with the blockbusters. “Since the EP4 agonist acts on the intestinal epithelium, its mechanism of action differs from existing drugs that target the immune system, so we think it will most likely end up being used in combination,” Jefferies wrote. The fresh pact aligns with recent comments from AbbVie CEO Rob Michael, who said on last week’s earnings call that the pharma has the capacity for more acquisitions and would prefer bolt-on transactions over another megadeal like AbbVie’s $63 billion Allergan buy in 2020.

Phase 1License out/inAcquisition

30 Oct 2026

·www.fiercepharma.com

As Skyrizi and Rinvoq dominate AbbVie's Q3, analysts ask what's next

Even as AbbVie has demonstrated that Rinvoq and Skyrizi sales can more than make up for Humira's tumble over the patent cliff, analysts appear anxious to know what the Chicago drugmaker might bring to the table next. During a third-quarter earnings call Friday, executives at the pharma were peppered with queries about the company’s plans outside immunology. One Morgan Stanley analyst inquired after AbbVie’s appetite for deals following its recent $10.9 billion Apogee acquisition and asked if the drugmaker needed a GLP-1 to be able to compete at scale in the market. AbbVie’s CEO Rob Michael said that deal focus remains on differentiated assets in the company’s core areas of immunology, neuroscience and oncology, but he added that the company is “looking to expand in obesity as well.” Across the portfolio, AbbVie is open to early-stage, late-stage, or even on-market deals, the CEO said. The Apogee buy reinforced AbbVie's immunology leadership, gaining the company access to Apogee's late phase long-acting eczema treatment zumilokibart. While there have been no head-to-head trials, efficacy data on Apogee's treatment appears to be as strong as market leaders like Eli Lilly’s Ebglyss and Sanofi and Regeneron’s Dupixent, albeit with the potential added benefit of fewer injections. Meanwhile, Michael was adamant that the company’s existing portfolio and pipeline are enough for “long, durable growth” well into the 2030s. “We have ample financial capacity to pursue the deals we’re interested in,” he added. According to Citi analysts, that balance of business development and internal pipeline execution will “remain necessary to strengthen [AbbVie’s] 2030+ growth profile.” Other analysts on Friday's call asked after Epkinly’s competitive edge amid building competition in the front-line diffuse large B-cell lymphoma (DLBCL) landscape, where the drug is vying for an approval. AbbVie CMO Roopal Thakkar pointed to the Epkinly regimen’s simplicity—one product plus standard-of-care R-CHOP—which he said resonated with clinicians. In Q3, AbbVie reported $108 million in sales for Epkinly, a 58% jump from the same time last year. After a phase 3 first-line win this month, AbbVie said it was working with regulators on next steps. Incyte is after the same first-line approval with its tafasitamab and lenalidomide combination plus R-CHOP after a phase 3 win this summer. While there were questions this week about the company's longer-term prospects, AbbVie’s present performance was decidedly strong in the third quarter. Skyrizi and Rinvoq hit $5.8 billion and $2.7 billion in sales, respectively, driving 16% reported year-over-year growth for AbbVie’s immunology portfolio in spite of a 31% decline from the biosimilar-assailed Humira. On the psoriasis front specifically, AbbVie's CEO also sought to quell concerns about J&J’s newly launched oral IL-23 Icotyde. “Recent oral competition is not having a substantive impact on our in-play patient share, with Skyrizi continuing to capture one out of every two new or switching psoriasis patients,” Michael said. The company’s neuroscience portfolio is also gaining visibility, according to Citi, and produced the pharma’s strongest beats of the quarter. The franchise was up 19% year over year to $3.3 billion, led by Vraylar and Botox Therapeutics, which both brought home just over $1 billion for the quarter. The pharma now expects annual adjusted profits of $13.95 to $13.99 per share, up from $13.76 to $13.96. It also raised its sales guidance for 2026 by $200 million to $67.8 billion. Meanwhile, a key readout for AbbVie’s phase 3 trial testing Rinvoq in hidradenitis suppurativa (HS) remains on track for the end of the year.

Phase 3AcquisitionClinical ResultBiosimilar

100 Deals associated with Upadacitinib hemihydrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10994 D11048	Upadacitinib hemihydrate	L04AF03	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	ycnsvvsrka(dpjcjlfzcz) = bhoseijbgw ntdzrihnlh (oolafksaam )	Positive	31 Dec 2026
				Upadacitinib	ycnsvvsrka(dpjcjlfzcz) = ncuzaspqjj ntdzrihnlh (oolafksaam )
ACR2026	Not Applicable	Giant Cell Arteritis	40	Upadacitinib	vpqnxxiqzu(axfjcilcks) = ukaslivdog fdbpohnohf (rfhakcgbua ) View more	Positive	06 Nov 2026
ACR2026	Not Applicable	Arthritis, Psoriatic	145	Upadacitinib 15 mg daily	kzlitqdcsn(jaolyzpxqj): Difference (%) = 8.8 (95.0% CI, -1.7 to 19.3), P-Value = 0.0997 View more	Positive	06 Nov 2026
				Deucravacitinib 6 mg daily
SELECT-GCA (ACR2026)	Phase 3	Giant Cell Arteritis	101	Upadacitinib 15 mg	rppkjldhhd(xkasjhktta) = The increase in mean (SD) levels of CRP from period 2 entry to the first flare was 0.7 (2.6) mg/dL for the UPA15/UPA15 group and 2.2 (2.2) mg/dL for the UPA15/PBO group. lmclmxxosp (sgroajdjgl ) View more	Positive	06 Nov 2026
				Placebo
ACR2026	Not Applicable	Rheumatoid Arthritis	75	Tofacitinib	yjhkcuvlhr(zarvzcvrtz) = otuuwhvbuz wfilevuebd (cufmuyxkwb ) View more	Positive	06 Nov 2026
				Upadacitinib	wqyzezekkz(cxzlgcdbas) = ebiwzljsnx sszuwvxtkk (wxfblsgdsw )
ACR2026	Not Applicable	Arthritis, Psoriatic \| Rheumatoid Arthritis	36,793	Upadacitinib	nefqniqdzm(mbtmqtnfuh) = The prespecified positive control of incident herpes zoster was directionally elevated for both JAK inhibitors and near null for negative control outcomes. gjfayyfwpo (apozinaras ) View more	Positive	06 Nov 2026
				Tofacitinib
UPHOLD (ACR2026)	Not Applicable	Rheumatoid Arthritis	1,494	Upadacitinib (Remission)	vosqruljou(ivmtnioimy) = jqqeevbrgw niwczmvubq (immigvnksw ) View more	Positive	06 Nov 2026
				Upadacitinib (LDA)	vosqruljou(ivmtnioimy) = kewyzgwulk niwczmvubq (immigvnksw ) View more
SELECT-GCA (ACR2026)	Phase 3	Giant Cell Arteritis CRP \| ESR	274	Upadacitinib 15 mg	uolpfsljqx(iqdlfkmajk) = jbprcvbwmj xaicbbcjgc (ycknolelhi, 43.1 - 79.7) View more	Positive	06 Nov 2026
ACR2026	Not Applicable	Arthritis, Psoriatic	1,797	Upadacitinib	okvkinkaet(orcmpwpssy) = hcykurwtwz rclafpxsqo (mdaatjzwjj, -1.50 to -0.85) View more	Positive	06 Nov 2026
				Interleukin-17 inhibitor (IL-17i)	okvkinkaet(orcmpwpssy) = kmezzotevm rclafpxsqo (mdaatjzwjj, -1.02 to -0.6) View more
ACR2026	Not Applicable	Rheumatoid Arthritis	27,586	Tofacitinib	anmvdvnllo(vlmatuxtsg) = uanvjhyfhc wpyaggpjza (bingtlrddh ) View more	Positive	06 Nov 2026
				Upadacitinib/Baricitinib	anmvdvnllo(vlmatuxtsg) = xqtnpdqkdh wpyaggpjza (bingtlrddh ) View more

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