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Last update 28 Jun 2025

Inebilizumab-cdon

Last update 28 Jun 2025

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Inebilizumab, Inebilizumab (Genetical Recombination), 英比利珠单抗

+ [9]

Target

CD19

Action

inhibitors

Mechanism

CD19 inhibitors(B-lymphocyte antigen CD19 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [5]

Active Indication

Immunoglobulin G4-Related DiseaseAQP4-IgG positive Neuromyelitis optica spectrum disorderNeuromyelitis Optica+ [4]

Inactive Indication

Aggressive B-Cell Non-Hodgkin LymphomaB-Cell Malignant NeoplasmCD19 Expressing Malignancies+ [9]

Originator Organization

Duke University

Active Organization

Amgen, Inc.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Mitsubishi Tanabe Pharma Corp.

+ [7]

Inactive Organization

MedImmune LLC

AstraZeneca PLC

License Organization

MedImmune Pharma BV

Amgen, Inc.Horizon Therapeutics Ltd. (Ireland)

+ [3]

Drug Highest PhaseApproved

First Approval Date

United States (11 Jun 2020),

Neuromyelitis Optica

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

Structure/Sequence

Sequence Code 319372678L

Source: *****

Sequence Code 1191632826H

Source: *****

Clinical Trials associated with Inebilizumab-cdon

NCT07010302

/ Not yet recruitingPhase 4IIT

A Comparative Clinical Effectiveness Trial of Rituximab Versus Ravulizumab, Inebilizumab, Satralizumab and Eculizumab To Prevent Relapses in Neuromyelitis Optica Spectrum Disorder

Neuromyelitis Optica Spectrum Disorder (NMOSD) is a rare autoimmune condition that mainly affects the eyes and spinal cord, causing serious symptoms such as vision loss, paralysis, and severe pain. This trial compares the effectiveness and safety of five medications commonly used to prevent NMOSD relapses: rituximab, ravulizumab, inebilizumab, satralizumab, and eculizumab.
In this study, 160 adults with NMOSD who test positive for a specific antibody (AQP4-IgG) will participate. They will be randomly assigned to receive either rituximab or one of the four other FDA-approved medications. The main goal is to find out which treatment best prevents relapses and has fewer serious side effects. The trial will also measure disability, patient satisfaction, quality of life, and biomarkers that help track disease activity.
Participants will have regular assessments, including medical exams, surveys, and tests for vision, walking ability, and brain function. They will report any side effects or health issues experienced during the study. The trial will last from one to four years for each participant.
This research aims to help patients and doctors make better-informed treatment decisions by providing clear evidence about the best available therapies for NMOSD.

Start Date01 Nov 2025

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT06987539

/ Not yet recruitingPhase 2

A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG)

The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.

Start Date29 Aug 2025

Sponsor / Collaborator

Amgen, Inc.

NCT06570798

/ RecruitingPhase 2

A Phase 2a, Open Label, Multicenter, 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 Date30 Jun 2025

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Inebilizumab-cdon

100 Translational Medicine associated with Inebilizumab-cdon

100 Patents (Medical) associated with Inebilizumab-cdon

127

Literatures (Medical) associated with Inebilizumab-cdon

01 Jul 2025·Neurology-Neuroimmunology & Neuroinflammation

Neutropenia Associated With B Cell–Depleting Therapies in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder

Article

Author: Waldrop, Greer ; Sisodia, Nikki ; Bove, Riley ; Gelfand, Jeffrey M. ; Pleasure, Samuel ; Zamvil, Scott S. ; Wilson, Michael R. ; Guo, Chu-Yueh ; Poole, Shane

BACKGROUND AND OBJECTIVES:

Neutropenia is described as a rare adverse event associated with B cell-depleting therapy (BCDT) use in patients with multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD). However, little is known about longitudinal clinical outcomes. We estimated the real-world incidence of neutropenia among patients with neuroinflammatory disease treated with BCDT and characterized the clinical course.

METHODS:

We conducted a retrospective cohort study using electronic medical records to estimate the incidence rate of neutropenia in adults with MS/NMOSD from a neuroimmunology clinic in California between January 6, 2006, and November 2, 2015, treated with ocrelizumab, rituximab, ofatumumab, ublituximab, or inebilizumab. Each clinical course (recurrence, time to recovery of absolute neutrophil count [ANC], postneutropenia treatment) of neutropenia was then presented in a case series.

RESULTS:

In this cohort of 1,825 patients (6,009 person-years on BCDT), the largest cohort addressing this question to date, 37 developed neutropenia. The estimated incidence rate of neutropenia was 0.62 (95% CI 0.45-0.85) per 100 person-years. The median time from last infusion of current BCDT was 4 months (interquartile range [IQR] 1-6). The median nadir ANC was 390 (IQR 40-960); the nadir ANC was 0 for 6 patients (16%). All patients ultimately recovered to normal counts, except 2 patients developing fluctuating ANCs for months. Among the 32 patients not receiving filgrastim, the median time to ANC recovery was 11 days (95% CI 7-26). Course severity was asymptomatic/mild in 32% (n = 12) while 54% (n = 20) required hospitalization. A confirmed simultaneous infection or infectious prodrome occurred in 23 (62%). After recovery, 30 patients (81%) continued BCDT and 2 (7%) changed within BCDT class. Neutropenia recurred in 13 patients (35%), including 3 who discontinued BCDT after initial neutropenia. The estimated incidence rate of recurrent neutropenia was 0.22 (95% CI 0.13-0.39) per 100 person-years. The mean (SD) time to recurrence from initial neutropenia was 251 (SD: 355) days.

DISCUSSION:

This study is comprehensive and reflects a large cohort, examining incidence rates of neutropenia with BCDT in MS and NMOSD. Overall, neutropenia was still rare, occurring at a rate of 0.66 per 100 person-years, and infections were associated triggers in some patients. Yet, of relevance to clinicians, neutropenia was not benign: half required hospitalization and 35% experienced recurrence, which is higher than what was reported in clinical trials.

19 Jun 2025·NEW ENGLAND JOURNAL OF MEDICINE

A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis

Article

Author: Leite, M. Isabel ; Cheng, Sue ; Rojavin, Mikhail ; Tang, Fengming ; Nowak, Richard J. ; Benatar, Michael ; Ciafaloni, Emma ; Vissing, John ; Utsugisawa, Kimiaki ; Li, Qing ; Rampal, Nishi ; Wu, Yanping ; Howard, James F.

BACKGROUND:

Autoimmune generalized myasthenia gravis is a disease that manifests with fluctuating muscle weakness. Inebilizumab is a monoclonal antibody that depletes CD19+ B cells, which are central to disease pathogenesis.

METHODS:

In this phase 3, double-blind, randomized, placebo-controlled trial, we enrolled participants with myasthenia gravis who had anti-acetylcholine receptor antibodies or anti-muscle-specific kinase antibodies. Participants were randomly assigned, in a 1:1 ratio, to receive intravenous inebilizumab (300 mg administered on days 1 and 15 for all, and additionally on day 183 for participants who were acetylcholine receptor antibody-positive) or matching placebo for 52 weeks (in participants who were acetylcholine receptor antibody-positive) or 26 weeks (in those who were muscle-specific kinase antibody-positive). Glucocorticoid therapy was tapered, starting at week 4, to a target of 5 mg per day by week 24. The primary end point was the change from baseline in the score on the Myasthenia Gravis Activities of Daily Living scale (MG-ADL; scores range from 0 to 24, with higher scores indicating greater disease activity) at week 26 in the combined acetylcholine receptor antibody-positive and muscle-specific kinase antibody-positive trial populations. A key secondary end point was the change from baseline in the score on the Quantitative Myasthenia Gravis scale (QMG; scores range from 0 to 39, with higher scores indicating greater disease activity) at week 26 in the combined population. Safety was assessed.

RESULTS:

A total of 238 participants underwent randomization (119 per group). Participants who received inebilizumab had a greater reduction in the MG-ADL score than those who received placebo (least-squares mean change, -4.2 vs. -2.2; adjusted difference, -1.9; 95% confidence interval [CI], -2.9 to -1.0; P<0.001) at week 26. Participants who received inebilizumab had a greater reduction in the QMG score than those who received placebo (least-squares mean change, -4.8 vs. -2.3; adjusted difference, -2.5; 95% CI, -3.8 to -1.2; P<0.001). The most common adverse events with inebilizumab were headache, cough, nasopharyngitis, infusion-related reactions, and urinary tract infections. Inebilizumab was not associated with a higher incidence of serious adverse events.

CONCLUSIONS:

In participants with acetylcholine receptor antibody-positive or muscle-specific kinase antibody-positive generalized myasthenia gravis, inebilizumab improved function and reduced disease severity. (Funded by Amgen; MINT ClinicalTrial.gov number, NCT04524273.).

01 Jun 2025·CNS DRUGS

The Evolution of Anti-CD20 Treatment for Multiple Sclerosis: Optimization of Antibody Characteristics and Function

Review

Author: Greenberg, Benjamin ; Cree, Bruce A C ; Berger, Joseph R

B-cell depletion with CD20-targeted agents is commonly used for treatment of multiple sclerosis (MS), other autoimmune diseases, and certain hematologic malignancies. Initial apparent success with rituximab in MS and neuromyelitis optica spurred development of the anti-CD20 monoclonal antibody (mAb) therapies ocrelizumab, ofatumumab, and ublituximab as well as the anti-CD19 mAb inebilizumab. While each are effective at targeting and depleting B cells, structural differences translate into different mechanisms of action affecting maintenance of B-cell depletion and safety and tolerability. Although the anti-CD20 mAbs differ in degree of human versus mouse sequences as well as target CD20 epitope, these properties do not appear to substantially affect activity or tolerability. In contrast, an antibody-dependent cell-mediated cytotoxicity (ADCC) versus a complement-dependent cytotoxicity mechanism of action as well as subcutaneous versus intravenous administration may provide improved tolerability. Glycoengineering of the mAbs ublituximab and inebilizumab enhances ADCC and can overcome the reduced responses to mAb-mediated B-cell depletion associated with certain genetic polymorphisms. Other strategies for therapeutic targeting of CD20, including brain shuttle antibodies (e.g., RO7121932), bispecific antibodies, chimeric antigen receptor T-cell therapies, and antibody-drug conjugates, are in active clinical development and may be future treatment approaches in MS and other B-cell-mediated autoimmune diseases.

140

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

·pharma.economictimes.indiatimes.com

Amgen posts profit, says tax policy more effective than tariffs

By Deena Beasley New York: Amgen on Thursday said its first-quarter profit rose 24%, driven by product sales, and said that while it is premature to speculate on the impact of U.S. tariffs, tax policy would be a more effective way to influence U.S. manufacturing. President Donald Trump's administration has opened a national security investigation into pharmaceuticals in a bid to demonstrate why the U.S. needs tariffs to increase domestic manufacturing. "We agree with our peers that the most effective answer is not tariffs, but tax policy," Amgen CFO Peter Griffith said on a conference call. Johnson & Johnson CEO Joaquin Duato, last month said tariffs on pharmaceuticals can create supply chain disruptions and favorable tax policies would be a more effective tool to boost U.S. manufacturing capacity of both drugs and medical devices. Pharmaceutical companies in recent decades moved production capacity outside of the U.S., including to European Union countries like Ireland, in part because of lower income-tax rates for intellectual property. Amgen recently announced a $900 million expansion of its Ohio biotech manufacturing facility, joining a number of other drugmakers, including Eli Lilly, Merck and J&J, pledging to increase U.S. plant capacity. For the first quarter, Amgen reported adjusted earnings per share of $4.90, beating the average analyst estimate of $4.30, as compiled by LSEG. Revenue rose 9 per cent to $8.1 billion, which was in line with Wall Street estimates. Shares of the biotechnology company, which fell more than 2 per cent in regular trading, were up about 1 per cent at $286 after hours. For the full year, Amgen said it still expects adjusted earnings per share of $20.00 to $21.20 on revenue of $34.3 billion to $35.7 billion. Analysts, on average, have estimated earnings of $20.63 per share on revenue of $35.1 billion. Amgen said its 2025 outlook includes the impact of implemented tariffs, but does not account for any future levies, including potential sector-specific tariffs. The company is slated to present at a medical meeting next month full results from a mid-stage trial of its experimental weight-loss drug MariTide, viewed by many investors as a potential blockbuster. Amgen is conducting late-stage trials of the drug in patients with and without diabetes, and results from a Phase 2 diabetes trial will be announced later this year. The company also said the U.S. Food and Drug Administration has lifted its clinical hold on an early-stage trial of a different experimental weight-loss drug known as AMG 513. The first-quarter results "suggest momentum for established products, but uncertainty is apparent in the newer growth portfolio, both of which highlight the importance of obesity as a future driver for shares," Citi Research analyst Geoff Meacham said in a note to clients. Amgen's sales of bone drug Prolia rose 10 per cent to $1.1 billion, but the company said it expects lower sales of the medication later in the year as biosimilar competitors are launched. Sales of cholesterol-lowering medication Repatha rose 27 per cent to $656 million, while sales of arthritis drug Enbrel fell 10 per cent to $567 million. In the rare disease space, sales of thyroid eye disease drug Tepezza fell 10% to $381 million, and sales of gout treatment Krystexxa were flat at $236 million. Both were acquired with Amgen's 2023 purchase of Horizon Therapeutics. Sales of rare disease drug Uplinza rose 14 pr cent to $91 million. Amgen said the FDA has accepted its application seeking approval of Uplinza as a treatment for myasthenia gravis, with a decision due by December 14. (Reporting By Deena Beasley Editing by Bill Berkrot and Deepa Babington)

AcquisitionDrug ApprovalPhase 2

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	Horizon Therapeutics Ireland DAC	03 Apr 2025
Immunoglobulin G4-Related Disease	United States	Amgen, Inc.	03 Apr 2025
AQP4-IgG positive Neuromyelitis optica spectrum disorder	European Union	Amgen Europe BV	25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Iceland	Amgen Europe BV	25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Liechtenstein	Amgen Europe BV	25 Apr 2022
AQP4-IgG positive Neuromyelitis optica spectrum disorder	Norway	Amgen Europe BV	25 Apr 2022
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
Myasthenia Gravis	NDA/BLA	China	AstraZeneca Nijmegen BV	30 May 2025
Myasthenia Gravis	NDA/BLA	China	Horizon Therapeutics Ireland DAC	30 May 2025
Myasthenia Gravis	NDA/BLA	China	Changzhou Hansoh Pharmaceutical Co., Ltd.	30 May 2025
Scleroderma, Systemic	Phase 3	Japan	Mitsubishi Tanabe Pharma Corp.	20 Jul 2022
Systemic Lupus Erythematosus	Phase 2	United States	Amgen, Inc.	30 Jun 2025
Systemic Lupus Erythematosus	Phase 2	Belgium	Amgen, Inc.	30 Jun 2025
Systemic Lupus Erythematosus	Phase 2	France	Amgen, Inc.	30 Jun 2025
Systemic Lupus Erythematosus	Phase 2	Germany	Amgen, Inc.	30 Jun 2025
Systemic Lupus Erythematosus	Phase 2	Italy	Amgen, Inc.	30 Jun 2025
Systemic Lupus Erythematosus	Phase 2	Spain	Amgen, Inc.	30 Jun 2025

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	flbeiivjwq(gttbgyqbhm): adjusted difference = -1.9 (95% CI, -2.9 to -1.0) View more	Positive	19 Jun 2025
				Placebo
P9-1.008 (AAN2025)	Phase 3	Neuromyelitis Optica AQP4-IgG positive	42	Inebilizumab	sfhesihziq(fjxbozhcbv) = 0.20±0.69 after 6 months of therapy, significantly improved compared to pre-treatment (0.81±0.68) cflkbqdhly (gnshtekjnf ) View more	Positive	07 Apr 2025
P12-8.013 (AAN2025)	Not Applicable	Neuromyelitis Optica	13	Inebilizumab	dzxjkdgtnz(hozyewkcue) = yyjmayrmmy kfkltqfzbv (cpaufdczxi ) View more	Positive	07 Apr 2025
				Inebilizumab (Control Group (Immunosuppressant Treatment))	dzxjkdgtnz(hozyewkcue) = fyrzsajhfu kfkltqfzbv (cpaufdczxi ) View more
NCT04540497 (FDA_CDER) Manual	Phase 3	Immunoglobulin G4-Related Disease	135	UPLIZNA	gpwhjmwaht(vlhewoveeg) = kghnumzzwa ngyqimbgnn (wbycgmgftt ) View more	Positive	03 Apr 2025
				Placebo	gpwhjmwaht(vlhewoveeg) = gwobxkjkxh ngyqimbgnn (wbycgmgftt ) View more
NCT04540497 (MITIGATE, ACR2024 \| Literature) Manual	Phase 3	Immunoglobulin G4-Related Disease	135	Placebo	omzkbvglhg(zghbkpikvd) = wrlxfrutzw kznvfrfpyu (ugcgfxspmt ) View more	Positive	16 Nov 2024
				inebilizumab	omzkbvglhg(zghbkpikvd) = bhyokdgvpb kznvfrfpyu (ugcgfxspmt ) View more
NCT04524273 (MINT, Company_Website \| NEWS) Manual	Phase 3	Myasthenia Gravis	238	UPLIZNA	iezxbhqlyq(inidpvnifb) = kwettbeqlj xlaxoabboy (pdmsahrmbk ) Met View more	Positive	15 Oct 2024
				Placebo	iezxbhqlyq(inidpvnifb) = ygzvaubkjs xlaxoabboy (pdmsahrmbk ) Met View more
NCT02200770 (N-ÂMomentum, EAN2024)	Phase 2/3	Neuromyelitis Optica	213	Inebilizumab 300mg	hnjfoqxpda(wuxgmwfgje) = 50% (3/6) of inebilizumab and 75% (3/4) of placebo participants â‰¥65âyears aumkvzkryh (vxgxpucfqx )	Positive	28 Jun 2024
				Placebo
NCT04540497 (MITIGATE, NEWS) Manual	Phase 3	Immunoglobulin G4-Related Disease	-	Uplizna	gbqgsaylmy(qbdiabzgyf) = vablcabxdu ykcvzzvema (rvtzenmdmb ) Met	Positive	06 Jun 2024
				Placebo	-
NCT02200770 (N-MOmentum, AAN2024)	Phase 2/3	Neuromyelitis Optica AQP4+	208	Inebilizumab	hrejmawejk(oaumtoqckf): HR = 0.29 (95% CI, 0.17 - 0.42)	Positive	09 Apr 2024
				Azathioprine and other immunosuppressants
NCT02200770 (N-MOmentum, AAN2024)	Phase 2/3	Neuromyelitis Optica IL-17a \| LAP-TGF-β-1 \| CXCL10 ... View more	211	Inebilizumab	vymmlqvesw(zfbnadzkej) = qltvcnpahp bkcrwwrejl (hlpubuphnd ) View more	Positive	09 Apr 2024
				Placebo	vymmlqvesw(zfbnadzkej) = hyrithacew bkcrwwrejl (hlpubuphnd ) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis