RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea)

Structure/Sequence

Sequence Code 319372678L

Source: *****

Sequence Code 1191632826H

Source: *****

Clinical Trials associated with Inebilizumab-cdon

NCT06570798

/ Not yet recruitingPhase 2

A Phase 2a, Open Label, Multi Center, Platform Trial to Assess the Safety, Tolerability, and Efficacy of Inebilizumab and Blinatumomab in Subjects With Autoimmune Diseases

The main objective is to assess the safety and tolerability of inebilizumab in adult participants with active and refractory systemic lupus erythematosus (SLE) with nephritis (Subprotocol A) and to assess the safety and tolerability of subcutaneous (SC) blinatumomab in adult participants with active and refractory (SLE) with nephritis (Subprotocol B) and in adult participants with active refractory rheumatoid arthritis (RA) (Subprotocol C).

Start Date16 May 2025

Sponsor / Collaborator

Amgen, Inc.

NCT05909761

/ RecruitingNot Applicable

An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Start Date14 Apr 2025

Sponsor / Collaborator

Amgen, Inc.

NCT05891379

/ RecruitingNot ApplicableIIT

Effectiveness and Safety of Inebilizumab in the Acute Phase of Neuromyelitis Optica Spectrum Disorders-a Multicentric, Prospective, Real Word Study

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

Start Date09 Jul 2024

Sponsor / Collaborator

Xuanwu Hospital Capital Medical University

100 Clinical Results associated with Inebilizumab-cdon

100 Translational Medicine associated with Inebilizumab-cdon

100 Patents (Medical) associated with Inebilizumab-cdon

123

Literatures (Medical) associated with Inebilizumab-cdon

01 Jun 2025·Multiple Sclerosis and Related Disorders

Neuromyelitis optica spectrum disorder in Latin America: a global data share initiative

Article

Author: Weiser, Roberto ; Delgado, Jaime ; Candanedo, Awilda ; Carrillo, Gabriela ; de Queiroz, André Luiz Guimarães ; Yorio, Diana ; Garcia, Karla ; Valladares Velez, Jonathan A ; Santos Pujols, Biany ; Correa Diaz, Edgar P ; Llerena Payango, Andrea F ; Legnani, Cecilia ; Lopez, Ericka ; de Escobar, Romy ; Oliveira de Cuba, Irma ; Lana Peixoto, Marco ; Rojas, Juan I ; Ortiz Salas, Paola A ; Ramirez, Deyanira ; Galleguillos, Lorna ; Miranda, Jhair ; Garcia Valle, Luis A ; Larrategui, Mario ; Treviño Frenk, Irene ; Van Sijtveld, Ivonne ; Baños-Hernández, Lilia Anahi ; Guio Sanchez, Claudia ; Sorondo, Noelia ; Gortari, José I ; Becker, Jefferson ; Pereira, Daniel ; Valderrama, Carlos ; Portillo Rivera, Ligia I ; Rodriguez Salinas, Luis C ; Diaz, Alejandro ; Thompson, Arnold ; Zuluaga Rodas, María I ; Higgie, Juan Ramón ; Patrucco, Liliana ; Gracia, Fernando ; Ramirez Sanchez, Nicia E ; Diaz de la Fe, Amado ; Soto Del Castillo, Ibis ; Soares Neto, Herval Ribeiro ; Cristiano, Edgardo ; Corea, Karla ; Acosta Camargo, Laura C ; Benzadon, Aron ; Rocha, Valeria ; Carnero Contentti, Edgar ; Araujo, Pahola ; Armien, Blas

The objective of the study was to develop a global data share initiative to collect data from many sources (registries and observational databases) of NMOSD (neuromyelitis optica spectrum disorder) patients in LATAM (Latin America) to describe the frequency of patients untreated in our region to focus access and educational projects to improve patients care and long-term outcomes. METHODS: This was a non-interventional, multicenter cross-sectional study that included NMOSD patients from LATAM. Data were acquired through independent registries and observational single and multicenter cohorts from 16 countries (Argentina n = 379, Brazil n = 250, Chile n = 50, Colombia n = 250, Ecuador n = 47, Mexico n = 101, Uruguay n = 10, Venezuela n = 31, Aruba n = 4, Cuba n = 13, El Salvador n = 7, Guatemala n = 23, Honduras n = 7, Nicaragua n = 6, Panama n = 42 and Dominican Republic n = 48). Data homogenization was conducted using the data dictionary provided by each custodian in a single, centralized database with variables loaded in a homogeneous manner. RESULTS: A total of 1264 patients were included from three nationwide registries and seven observational cohorts from LATAM. 90.8 % (n = 1148) patients were receiving long-term treatment for NMOSD, while 9.2 % (n = 116) were untreated. Most frequent treatment received in the analyzed population was rituximab (56.7 %), followed by azathioprine (28 %). Despite the availability of novel therapeutic options such as satralizumab, eculizumab, and inebilizumab, these were used in <5 % of AQP4-IgG-positive patients CONCLUSION: The study helps to understand how patients are being treated in the region and to develop educational and access strategies to improve patients care.

04 Apr 2025·MEDICINE

Satralizumab after inebilizumab treatment in a patient with recurrent neuromyelitis optica spectrum disorder: A case report

Article

Author: Hong, Zhaoxiang ; Xiao, Haibing ; Ye, Jinhao ; Li, Duanyang

Rationale::

Neuromyelitis optica spectrum disorder (NMOSD) comprises a group of rare and severe autoimmune inflammatory diseases affecting the central nervous system, mainly the optic nerves and spinal cord. Phase III studies have shown that the incidence of relapse is significantly reduced in aquaporin (AQP) 4 antibody-positive patients after treatment with satralizumab, a humanized monoclonal recycling antibody that blocks interleukin (IL)-6 signaling pathways, in conjunction with inebilizumab, a B-cell-depleting agent. Here, we report our experience with a patient who presented with pain associated with NMOSD.

Patient concerns::

A 40-year-old woman initially presented with acute thoracic myelitis. Magnetic resonance imaging revealed a demyelinating lesion in the spinal cord spanning from T2 to T10, along with enhancement and a positive serum AQP4-immunoglobulin G (IgG) titer.

Diagnosis::

NMOSD.

Interventions::

The patient initially received adequate long-term immunotherapy with inebilizumab and corticosteroids. Satralizumab was administered after treatment failure.

Outcomes::

The patient experienced recurrences of the disorder despite the initial immunotherapy, including pain and immobility from neurological dysfunction. Furthermore, her serum AQP4-IgG titer remained elevated (1:320), her B-cell proportion remained at 0, and her symptoms were not adequately relieved. She was then administered satralizumab, after which her serum AQP4-IgG and IL-6 levels decreased, the radiological appearance of spinal cord demyelination improved, her pain and other symptoms were alleviated, and her neurological function gradually recovered.

Lessons::

In patients with clinical episodes of NMOSD that recur despite treatment with a B-cell-depleting agent, satralizumab may help alleviate myelitis-associated pain. Further investigations are warranted to establish IL-6 as a therapeutic target for the treatment of neuropathic pain, and may help address the unmet medical need in the management of NMOSD-associated neuropathic pain. As exemplified by the present case, individualized management, and therapy for patients with NMOSD are essential. Our case report provides new ideas for the management of patients with refractory NMOSD and patients with subsequent severe neuropathic pain.

27 Mar 2025·NEW ENGLAND JOURNAL OF MEDICINE

Inebilizumab for Treatment of IgG4-Related Disease

Article

Author: Stone, John H. ; Della Torre, Emanuel ; Cimbora, Daniel ; Löhr, J. Matthias ; Rebours, Vinciane ; Lanzillotta, Marco ; Khosroshahi, Arezou ; Perugino, Cory A. ; Umehara, Hisanori ; Nayar, Manu K. ; Li, Qing ; Martinez Valle, Fernando ; Culver, Emma L. ; Wallace, Zachary S. ; Webster, George J. ; Ebbo, Mikael ; Tanaka, Yoshiya ; Dong, Xinxin ; Zhang, Wen ; Wu, Yanping ; Dong, Lingli ; Okazaki, Kazuichi ; Rampal, Nishi ; Schleinitz, Nicolas

BACKGROUND:

IgG4-related disease is a multiorgan, relapsing, fibroinflammatory, immune-mediated disorder with no approved therapy. Inebilizumab targets and depletes CD19+ B cells and may be effective for treating patients with IgG4-related disease.

METHODS:

In this phase 3, multicenter, double-blind, randomized, placebo-controlled trial, adults with active IgG4-related disease underwent randomization in a 1:1 ratio to receive inebilizumab (300-mg intravenous infusions on days 1 and 15 and week 26) or placebo for a 52-week treatment period. Participants in both groups received identical glucocorticoid tapers. Glucocorticoids were allowed to treat disease flares, but background immunosuppressants were not permitted. The primary end point was the first treated, adjudicated disease flare during the treatment period, assessed in a time-to-event analysis. Key secondary end points were the annualized flare rate and treatment-free and glucocorticoid-free complete remission.

RESULTS:

A total of 135 participants with IgG4-related disease underwent randomization: 68 participants were assigned to receive inebilizumab and 67 were assigned to receive placebo. Treatment with inebilizumab reduced flare risk; 7 participants (10%) in the inebilizumab group had at least one flare, as compared with 40 participants (60%) in the placebo group (hazard ratio, 0.13; 95% confidence interval [CI], 0.06 to 0.28; P<0.001). The annualized flare rate was lower with inebilizumab than with placebo (rate ratio, 0.14; 95% CI, 0.06 to 0.31; P<0.001). More participants in the inebilizumab group than in the placebo group had flare-free, treatment-free complete remission (odds ratio, 4.68; 95% CI, 2.21 to 9.91; P<0.001) and flare-free, glucocorticoid-free complete remission (odds ratio, 4.96; 95% CI, 2.34 to 10.52; P<0.001). Serious adverse events occurred during the treatment period in 12 of the participants (18%) who received inebilizumab and 6 of the participants (9%) who received placebo.

CONCLUSIONS:

Inebilizumab reduced the risk of flares of IgG4-related disease and increased the likelihood of flare-free complete remission at 1 year, confirming the role of CD19-targeted B-cell depletion as a potential treatment for IgG4-related disease. (Funded by Amgen; MITIGATE ClinicalTrials.gov number, NCT04540497.).

135

News (Medical) associated with Inebilizumab-cdon

03 May 2025

·endpts.com

Earnings season continues; FDA delays PDUFA date; AACR recap; and more

Welcome back to Endpoints Weekly, our roundup of the top headlines in biopharma. Earnings season continued this week, with more comments from pharma executives on the potential impact of tariffs, new details around Pfizer and Moderna’s cost-efficiency efforts, and more. Read below for a recap of the top news out of this week’s earnings calls. We’ve also got a summary of data out of the American Association for Cancer Research’s annual meeting, where Lei Lei Wu reported from Chicago. And Endpoints News’ Andrew Dunn welcomed Arc Institute co-founder Patrick Hsu to our special Slack channel to discuss all things AI. Stay tuned next week as more companies, including BioNTech, Novo Nordisk, Takeda and more, report their earnings. — Nicole DeFeudis 💲 More pharma companies reported their Q1 earnings this week, including AstraZeneca, Novartis, Pfizer, GSK, Eli Lilly, Moderna and Amgen. Tariffs were a central theme during earnings calls, as drugmakers provided some detail on the potential impact to their business. “Our goal, as I mentioned, is to have 100% of our products produced in the US for the US,” Novartis CEO Vas Narasimhan said during a first-quarter earnings call with the media Tuesday. AstraZeneca CEO Pascal Soriot said the company “can actually move the manufacturing of products that are made in Europe, move it to the US for supply to the US. And we can also potentially do the other way around.” Here’s what else our reporters tracked: The privately-held biotech Stealth BioTherapeutics said its rare disease drug was delayed this week. A person familiar with the situation said the company hadn’t been asked to run more trials or provide more data, that the FDA hadn’t identified any safety concerns, and that the agency hadn’t raised manufacturing issues, Endpoints’ Max Gelman reported. The apparent delay comes amid upheaval at health agencies, though several companies have said in earnings calls and interviews in recent weeks that they aren’t seeing an impact on their interactions with the FDA so far. The agency made decisions on time for two other drugs this week: Johnson & Johnson’s rare disease drug Imaavy and Satsuma Pharmaceuticals’ migraine drug Atzumi. The agency also hit PDUFA dates for other big-name medicines in recent weeks, like Dupixent, Amvuttra, Uplizna and Eylea. Stealth’s drug had an original decision deadline in January, but the company said the FDA requested more time to review supplemental material. Max examines lingering questions around the situation here . AACR recap: Data from GSK, Merck and more 🔬Scientists descended on Chicago this week for the American Association for Cancer Research’s annual meeting. Some in attendance, including cancer scientists, former NIH leaders and patient advocates, spoke about how cuts to science funding could impact cancer research. “It is a time to be clear-eyed about what is happening and to decide what role each of us is willing to play,” Yale oncologist Patricia LoRusso said during a panel. Read more here . Elsewhere, GSK presented data showing that its PD-1 inhibitor Jemperli induced a 100% complete response rate in 49 patients with a specific type of rectal cancer after six months. Even though the results were excellent, Endpoints’ Elizabeth Cairns reported that they are unlikely to have major commercial implications. Jemperli is already approved in this cancer type, known as mismatch repair deficient (MMRd) solid tumors, though only after the patient has progressed on prior treatment and has no further options. The new data could move the product into the neoadjuvant setting for dMMR cancers, but it’s still a tiny patient population. Only around 3% of solid tumors carry the dMMR biomarker. Merck also impressed with Keytruda data in head and neck cancer, showing that adding Keytruda before and after surgery cut the risk of disease recurrence or death by 27%. Patients in the study remained disease-free for more than four years at the median. 🌎 The US’ drug infrastructure has historically been robust, making it an attractive country in which to run clinical trials. But some companies say uncertainty is driving them to look elsewhere for their studies. Jared Whitlock examined this phenomenon in a story this week . Of note, companies find FDA Commissioner Marty Makary’s comments on rare disease approval pathways and animal testing largely promising. “Since we are in the ultra-rare disease space, Makary’s words on creating paths for rare [diseases] creates hope, and we are looking forward to learning more about his plans,” Mahzi Therapeutics CEO Yael Weiss said. While overseas trials have limitations, agencies in Europe, Canada, Australia and the UK have worked in recent years to harmonize guidelines with the FDA. 🎤 Endpoints’ Andrew Dunn welcomed Patrick Hsu to the newsroom’s Slack channel earlier this month to share his thoughts from the frontlines of the AI bio space. Hsu co-founded the Arc Institute in 2021, a Palo Alto, CA-based nonprofit research organization that has spearheaded some leading AI biology research. “I think AI will become a universal copilot that we use for everything,” he said during the interview. Read more here . DON’T MISS:

Drug Approval

02 May 2025

·www.fiercepharma.com

As Amgen's trio of Horizon drugs disappoints, execs urge analysts to give them more time

In the first quarter, sales of the top three products Amgen gained from its $27.8 billion acquisition of Horizon Therapeutics fell far short of analyst expectations, with each seeing a double-digit sequential sales decline. It’s been 19 months since Amgen completed its $27.8 billion acquisition of Horizon Therapeutics, and the California company is still struggling to build momentum for three of the prized possessions of the deal—rare disease drugs Uplizna, Krystexxa and Tepezza.When Amgen presented its first-quarter earnings Thursday, none of the trio met analyst expectations. With sales of $91 million, Uplizna came up $20 million short of the consensus projection. Meanwhile, Krystexxa’s haul of $236 million was $57 million shy of expectations, and Tepezza’s $381 million figure was $69 million off the mark.The shortfall for the Horizon products came during a quarter in which most of the company’s other treatments exceeded expectations. In fact, Amgen’s overall revenue of $8.1 billion was a 9% increase year over year and topped the analyst consensus. The lack of success for the Horizon drugs is apparently becoming a sore subject for Amgen execs. During a conference call, after an analyst asked about the stagnant sales of Tepezza and referred to a “couple years” since the Horizon buyout, Chief Financial Officer Peter Griffith was quick to make a correction.“Just a reminder that the transaction closed in October of 2023,” Griffith said. “It’s been about a year and a half, although so much has happened in the world it might feel like more than that.”The most vexing Horizon product has been with Tepezza, which remains the lone drug on the market for thyroid eye disease. In its second full year on the market under Horizon, in 2022, it generated $1.96 billion in revenue. But, in the following year, sales came in at $1.77 billion, followed by $1.85 billion last year, when there were signs that Tepezza was rallying.But the $381 million quarterly result for the treatment was a stunner—it’s lowest figure for a three-month period since the first quarter of 2021 and a 17% sequential decline.“Sales of Tepezza and Krystexxa were adversely impacted in the quarter by changes to U.S. wholesaler inventory levels," Amgen’s chief commercial officer Murdo Gordon explained. "We do not expect similar deductions in inventory levels for the remainder of the year."But the result sounded an alarm bell with Mizuho Securities analyst Salim Syed, who noted the 9% decline in volume and 8% decrease in inventory levels, which “likely put the Horizon acquisition into even more question,” he wrote in a note to investors.Gordon explained that the initial uptake of Tepezza was strong as it was a long-awaited answer for people who had serious cases of the eye disease and were readily prescribed the treatment from plastic surgeons. To grow sales, Tepezza needs to secure more prescriptions from general ophthalmologist and endocrinologists, he added.But tapping this segment of the market “may be more challenging to penetrate than previously communicated by the company,” analysts from Citi wrote in a note to clients.Amgen is far from abandoning hope for Tepezza. The company recently gained a thumbs-up from Europe’s Committee for Medicinal Products for Human Use nd is ready to launch there upon an expected approval. An additional edge Amgen could secure to help spur sales would be to earn approval for a subcutaneous version of Tepezza, as opposed to the 60- to 90-minute infusions patients undergo every three weeks as it stands. A subQ option would allow patients to receive the treatment faster and in many more settings than at infusion centers. Testing on the formulation began last year.On a much smaller scale, sales also were disappointing for Uplizna, which fell sequentially from $101 million in the fourth quarter to $91 million in the first.But help has already arrived in the form of a label expansion last month, making Uplizna the first drug to win an FDA approval for immunoglobulin G4-related disease (IgG4-RD), a disease that affects 20,000 patients in the U.S. and has no standard of care. Additionally, Amgen announced Thursday that it has secured an FDA decision date of Dec. 14 for Uplizna to treat patients with generalized myasthenia gravis (gMG).With respect to all of the Horizon products, Amgen’s message on Thursday was to give them more time.“It’s a very young portfolio of products where we’re really just beginning to address the severe diseases that these drugs treat,” Jay Bradner, Amgen’s R&D chief, said. “Whether it’s Tepezza, Uplizna, Krystexxa or Tavneos, these are going to be key growth-driving products for us over the long haul.”

AcquisitionNDAClinical ResultAccelerated Approval

02 May 2025

·www.biopharmadive.com

Amgen’s Stelara biosimilar gets off to fast start

Dive Brief:Amgen on Thursday said its just-launched biosimilar of Johnson & Johnsons autoimmune drug Stelara recorded $150 million in sales in the first quarter, spotlighting rising revenue from the biotechs portfolio of copycat biologics.During the companys first quarter earnings call, commercial chief Murdo Gordon said Amgens biosimilar products recorded $735 million in sales, roughly 9% of the companys revenues. Those sales climbed 35% compared to the same period last year, showing the business continues to contribute meaningfully to our long-term growth, CEO Robert Bradway said.Still, Amgens overall performance is uneven. While some products are thriving, like an Avastin lookalike that booked $179 million in sales, others, such as its Humira biosimilar are struggling. Amgen recently launched a biosimilar version of Regenerons eye drug Eylea and could begin marketing a copycat form of AstraZenecas rare disease treatment Soliris sometime before the middle of the summer.Dive Insight:Amgen is nearly alone among its large drugmaker peers in committing to biosimilar drugs. But its decision has helped bolster revenues at a time when its own branded products are facing pressure from lookalike biologics.Amgens investment in biosimilars isnt slowing down, either. The company has in Phase 3 trials competitors to the checkpoint inhibitors that revolutionized cancer care over the past decade. The two top sellers, Bristol Myers Squibbs Opdivo and Merck & Co.s Keytruda, are due to lose patent protection in 2028, though subcutaneous versions of those drugs may complicate Amgens plans.Amgens best-selling biosimilars are even surpassing other high-profile medicines in its branded portfolio, such as the targeted cancer drug Lumakras and newer drugs like Uplizna and Tavneos. That shift is increasing scrutiny of Amgens pipeline of innovative drugs, most notably the obesity treatment MariTide. That drug so far has fallen short of investor expectations, but upcoming data presentations at the American Diabetes Association meeting in June could change sentiment. Amgen has multiple late-stage trials underway.Amgen recorded overall sales of $7.9 billion in the first quarter, up 11% over the same period in 2024 and exceeding consensus analyst estimates. Shares ticked down about 2% in early trading Friday. '

Phase 3BiosimilarDrug Approval

100 Deals associated with Inebilizumab-cdon

External Link

KEGG	Wiki	ATC	Drug Bank
-	Inebilizumab-cdon	L01XC	DB12530

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin G4-Related Disease	United States	Amgen, Inc.	03 Apr 2025
Immunoglobulin G4-Related Disease	United States	Horizon Therapeutics Ireland DAC	03 Apr 2025
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Canada	Horizon Therapeutics Ireland DAC	15 Dec 2023
Neuromyelitis Optica	United States	Horizon Therapeutics Ireland DAC	11 Jun 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Scleroderma, Systemic	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	20 Jul 2022
Myasthenia Gravis	Phase 3	United States	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	China	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Japan	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Argentina	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Belarus	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Brazil	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Canada	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	Denmark	Amgen, Inc.	15 Oct 2020
Myasthenia Gravis	Phase 3	France	Amgen, Inc.	15 Oct 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04524273 (MINT, Pubmed \| N Engl J Med)	Phase 3	Myasthenia Gravis anti-acetylcholine receptor antibodies \| anti-muscle-specific kinase antibodies	238	Inebilizumab	uerfrmmjte(lepkovikrg): adjusted difference = -1.9 (95% CI, -2.9 to -1.0) View more	Positive	08 Apr 2025
				Placebo
P12-8.013 (AAN2025)	Not Applicable	Neuromyelitis Optica	13	Inebilizumab	otpfizzzng(opqiszvpvj) = ndvywonbgh nsaqauxjjh (dksbtdsaqc ) View more	Positive	07 Apr 2025
				Inebilizumab (Control Group (Immunosuppressant Treatment))	otpfizzzng(opqiszvpvj) = pnnyfnrpac nsaqauxjjh (dksbtdsaqc ) View more
P9-1.008 (AAN2025)	Phase 3	Neuromyelitis Optica AQP4-IgG positive	42	Inebilizumab	udeqddzpez(zppnglecrv) = 0.20±0.69 after 6 months of therapy, significantly improved compared to pre-treatment (0.81±0.68) qhxcnmeyse (yybcbucgkd ) View more	Positive	07 Apr 2025
NCT04540497 (FDA_CDER) Manual	Phase 3	Immunoglobulin G4-Related Disease	135	UPLIZNA	kkfwcdltxp(wztpctkftu) = mqfdupngrr aypfnsuvcl (bqsurwwbke ) View more	Positive	03 Apr 2025
				Placebo	kkfwcdltxp(wztpctkftu) = bafoveumzm aypfnsuvcl (bqsurwwbke ) View more
NCT04540497 (MITIGATE, ACR2024 \| Literature) Manual	Phase 3	Immunoglobulin G4-Related Disease	135	Placebo	yoysedqvjj(rzfhmisaiy) = icixqtcndd uraaldhmyu (ckakxrvsih ) View more	Positive	16 Nov 2024
				inebilizumab	yoysedqvjj(rzfhmisaiy) = ctlliuoybi uraaldhmyu (ckakxrvsih ) View more
NCT04524273 (MINT, Company_Website \| NEWS) Manual	Phase 3	Myasthenia Gravis	238	UPLIZNA	adgtgklodn(oculeqqgwb) = avnigmbplz fodhmpbuxd (betagsbold ) Met View more	Positive	15 Oct 2024
				Placebo	adgtgklodn(oculeqqgwb) = pzyiabohnr fodhmpbuxd (betagsbold ) Met View more
NCT02200770 (N-ÂMomentum, EAN2024)	Phase 2/3	Neuromyelitis Optica	213	Inebilizumab 300mg	cmoiixjczj(yzmfemqazj) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants â‰¥65âyears oatagyniti (mvktvpoihv )	Positive	28 Jun 2024
				Placebo
NCT04540497 (MITIGATE, NEWS) Manual	Phase 3	Immunoglobulin G4-Related Disease	-	Uplizna	vbbbnocfpm(pukdycklvk) = btjuytqqet qpkrpcvwjm (cdjnpkbrhn ) Met	Positive	06 Jun 2024
				Placebo	-
NCT02200770 (N-MOmentum, ACTRIMS2024)	Phase 2/3	Neuromyelitis Optica AQP4+	213	Inebilizumab 300 mg	nuterdwoek(kykqanjjrh) = 16.0% (4/25) reported ≥1 investigational product-related treatment-emergent adverse event (IP-TEAE) versus 20.0% (3/15) on PBO, and among non-Hispanic/Latino participants, the IP-TEAE was 26.4% (36/136) in the INEB group and 27.0% (10/37) in the PBO group. No IP-related serious events or deaths occurred in the Hispanic/Latino participants in INEB or PBO groups of the RCP agvxrxpefm (lkjeuykhmi )	Positive	01 Mar 2024
				Placebo
ACTRIMS2024	Not Applicable	Sjogren's Syndrome \| Pancytopenia \| AQP4-IgG positive Neuromyelitis optica spectrum disorder	-	Inebilizumab 300 mg	idzsedpgdf(gfcdtxcqdy) = dkfmoqosyo khiwvckisn (neshbbjofb ) View more	-	01 Mar 2024

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