Delving into the Latest Updates on Efgartigimod Alfa with Synapse

RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Promising Innovative Medicine (United Kingdom), Priority Review (United States), Priority Review (China), Paediatric investigation plan (European Union)

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Structure/Sequence

Sequence Code 18457995

Source: *****

An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

This study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
The aim of this ISA1 is to evaluate the safety and therapeutic relevance of empasiprubart as add-on therapy to efgartigimod in participants with AChR-Ab seropositive generalized myasthenia gravis.
The ADAPT Forward master protocol is registered on https://clinicaltrials.gov/study/NCT07294170

Start Date19 Dec 2025

Sponsor / Collaborator

argenx SE

NCT07025330

/ RecruitingPhase 2IIT

A Phase IIa, Single-Site, Open-Label Study of Efgartigimod in Patients With IgG4-Related Disease

The goal of this clinical trial is to learn if efgartigimod can treat IgG4-related disease in adults. The main questions it aims to answer are:
In patients with IgG4-related disease, does treatment with efgartigimod reduce the volume of the:
* lacrimal gland(s) and/or
* salivary gland(s) and/or
* pancreas
Participants will:
* Receive efgartigimod once weekly for up to 12 weeks
* Visit the clinic every one to six weeks for checkups and tests
* Be asked to complete questionnaires to see how they feel on efgartigimod

Start Date12 Nov 2025

Sponsor / Collaborator

Stanford University

100 Clinical Results associated with Efgartigimod Alfa

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100 Translational Medicine associated with Efgartigimod Alfa

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100 Patents (Medical) associated with Efgartigimod Alfa

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250

Literatures (Medical) associated with Efgartigimod Alfa

31 Dec 2025·Human Vaccines & Immunotherapeutics

Impact of FcRn antagonism on vaccine-induced protective immune responses against viral challenge in COVID-19 and influenza mouse vaccination models

Article

Author: Vanhoenacker, Peter ; Baumeister, Judith ; Wouters, Heidi ; Schotsaert, Michael ; Laghlali, Gabriel ; Ulrichts, Peter ; Chang, Lauren A ; Singh, Gagandeep ; Binazon, Ornella ; Warang, Prajakta ; Elhemdaoui, Nadia ; Augustynková, Kateřina ; Moshir, Mahan ; Steeland, Sophie ; Notebaert, Margo

Antagonism of the neonatal Fc receptor through an engineered antibody Fc fragment, such as efgartigimod, results in a decrease in immunoglobulin G levels. This approach is being evaluated as a therapeutic strategy for the treatment of IgG-mediated autoimmune diseases. Our goal was to evaluate the impact of mFc-ABDEG, a mouse-adapted antibody Fc fragment with a mode of action highly similar to efgartigimod, on vaccine-induced protective immune responses against viral infections. Therefore, mouse vaccination models for COVID-19 and influenza were employed, utilizing an mRNA COVID-19 vaccine (COMIRNATY) and an adjuvanted, inactivated quadrivalent influenza vaccine (Seqirus+AddaVax), respectively. In both models, vaccination induced robust humoral responses. As expected, animals treated with mFc-ABDEG had lower levels of virus-specific IgG, while virus-specific IgM responses remained unaffected. The COVID-19 vaccine induced a strong Th1-type T cell response irrespective of mFc-ABDEG treatment. Influenza vaccination resulted in a poor T cell induction, regardless of mFc-ABDEG treatment, due to the Th2-biased response that inactivated influenza vaccines typically induce. Importantly, mFc-ABDEG treatment had no effect on protective immunity against live viral challenges in both models. Vaccinated animals treated with mFc-ABDEG were equally protected as the non-treated vaccinated controls. These non-clinical data demonstrate that FcRn antagonism with mFc-ABDEG did not affect the generation of vaccine-induced protective humoral and cellular responses, or protection against viral challenges. These data substantiate the clinical observations that, although IgG titers were reduced, FcRn antagonism with efgartigimod did not impair the ability to generate new specific IgG responses, regardless of the timing of vaccination.

01 Dec 2025·CLINICAL IMMUNOLOGY

Regarding the “Efgartigimod versus standard of care in new-onset AChR subtype generalized myasthenia gravis: A prospective cohort study”

Letter

Author: Hu, Shi-Min ; Li, Hai-Feng ; Guo, Yan-Su ; Han, Wei

01 Dec 2025·JOURNAL OF NEUROIMMUNOLOGY

Treatment strategy for myasthenia gravis with GAD65-IgG associated neurological disorders: A case report

Article

Author: Xu, Xiao-Na ; Li, Hui-Ning ; Li, Xin ; Yang, Chun-Sheng ; Yang, Shu ; Jiang, Wei ; Luo, Wen-Jun ; Wang, Jun-Ping

We present a clinically instructive case of a 50-year-old woman with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (MG) who subsequently developed glutamic acid decarboxylase 65 (GAD65) antibody-associated neurological disorders alongside a type B2 thymoma. This rare coexistence highlights the profound immune dysregulation induced by thymomas, wherein loss of self-tolerance emergence multiple concurrent autoimmune phenomena. The patient's favorable response to multimodal immunotherapy-including efgartigimod, high-dose corticosteroids, and rituximab-underscores the therapeutic imperative for early, targeted immunomodulation in such complex neuroimmunological syndromes. As no standardized treatment currently exists for MG with GAD65-IgG-associated neurological disorders, this case provides critical clinical insights into both the diagnostic and therapeutic approach for this complex disease.

358

News (Medical) associated with Efgartigimod Alfa

05 Jan 2026

·www.fiercepharma.com

As Vyvgart empire expands, argenx CEO passes reins to operating chief Karen Massey

Since the first approval of its flagship FcRn blocker, Vyvgart, in late 2021, argenx has ascended swiftly from biotech upstart to a commercial force in the rare disease space. After shepherding the company through its first approval and the successful launch of blockbuster autoimmune drug Vyvgart, argenx co-founder and chief executive Tim Van Hauwermeiren is passing the reins to the Dutch drugmaker’s operating chief.Karen Massey, who joined the Amsterdam-based immunology specialist as chief operating officer in early 2023, is now set to assume the role of CEO, the company announced on Monday. Hauwermeiren, who’s been with argenx since its inception in 2008, will take a step back to serve as a non-executive director and chairman of the company’s board.Van Hauwermeiren is himself succeeding Peter Verhaeghe as chairman of the board of directors, with the various leadership changes subject to shareholder approval at argenx’s upcoming annual meeting in early May, the company noted in its press release.“This leadership evolution comes at the right time and represents a natural step as we prepare for the next phase of growth at argenx,” Verhaeghe said in a statement Monday. “The board and I move forward with strong confidence in Tim as our incoming chairman, Karen as our trusted COO and incoming CEO, and the entire leadership team, to guide the organization towards Vision 2030 and beyond.”Since the first approval of its flagship FcRn blocker, Vyvgart (efgartigimod), in late 2021, argenx ascended swiftly from biotech upstart to a commercial force in the rare disease space. These days, the company can tout blockbuster sales of its drug across several indications and a market cap of around $50 billion.Argenx has yet to report full-year revenue for 2025, but in 2024, the company recorded $2.2 billion in product sales, buoyed exclusively by its efgartigimod franchise. In 2025’s third quarter, sales of Vyvgart and Vyvgart Hytrulo clocked in at $1.13 billion, growing 96% over the same period in 2024.Next on the docket is argenx’s Vision 2030 plan, unveiled at the company's R&D day back in 2024, under which the company has set the goal to push five new preclinical assets into phase 3 development and hold 10 approved indications across Vygart and other near-term potential launches by the start of the next decade. Argenx is also striving to reach 50,000 patients with its current and future medicines under that same 2030 deadline. “This is a special company with a bright future that is founded on the strength of our science, our entrepreneurial culture, and the deep accountability of our talented teams to transform the lives of our patients,” Massey said in argenx’s announcement Monday.“My commitment is to elevate the unique argenx DNA as we execute on Vision 2030 and beyond and to ensure we are making the most of this bold opportunity to build the biotech company of the future,” she continued.Much of argenx’s late-stage development work currently revolves around infused Vyvgart and its subcutaneous sibling Vyvgart Hytrulo. The company’s next most advanced asset, the C2-targeting antibody empasiprubart, is currently in phase 3 testing for multifocal motor neuropathy (MMN) and chronic inflammatory demyelinating polyneuropathy (CIDP).Argenx has largely prioritized the subcutaneous Vyvgart Hytrulo over its intravenous predecessor in its efforts. Vyvgart Hytrulo was initially cleared by the FDA in generalized myasthenia gravis (gMG) in June 2023 and subsequently picked up a U.S. green light in chronic inflammatory demyelinating polyneuropathy (CIDP) the following year.More recently, the FDA approved a prefilled syringe formulation of Vyvgart Hytrulo that patients can inject themselves at home. Prior to that FDA nod, Massey told Fierce Pharma in an interview last year that the prefilled syringe could help shift Vyvgart into earlier lines of therapy in gMG and build on the momentum of the drug’s 2024 launch in CIDP. Massey is set to become one of the few women CEOs spearheading a large commercial pharma company, especially as two prominent female leaders in the industry have recently telegraphed or made their exits.Back in September, Merck KGaA indicated that Belén Garijo, who helped steer the German healthcare and electronics conglomerate through the COVID-19 pandemic, is planning to end her five-year run at the company in April. Meanwhile, GSK’s Emma Walmsley officially stepped down from her post at the British drug giant on Jan. 1, handing over the CEO title to the company’s former chief commercial officer Luke Miels.

Executive ChangePhase 3Drug Approval

05 Jan 2026

·firstwordpharma.com

Biopharma bites: Aktis' IPO, argenx CEO swap and Moderna's mRNA flu play

Radiopharma IPOAktis is preparing to test the public markets with a proposed public offering that could raise over $200 million, joining a short list of companies attempting an IPO amid a prolonged sector downturn.In a US securities filing Monday, the Boston-based radiopharmaceutical developer said it plans to sell roughly 11.8 million shares at a range of $16 to $18 per share. At the midpoint, the company would raise $200.2 million and boast a fully diluted market cap of $860 million.The bulk of the capital will go toward expanding two programmes: approximately $140 million to $150 million to continue the ongoing Phase Ib trial of its lead candidate [225Ac]Ac-AKY-1189 for Nectin-4–expressing tumours, and $70 million to $80 million to advance [225Ac]Ac-AKY-2519 into a Phase Ib study for B7-H3–positive tumours.Aktis ended September with $246.2 million in cash, cash equivalents and marketable securities and expects its combined resources and IPO proceeds to fund operations into the first half of 2028.The company has raised at least $336 million privately, including an oversubscribed $175-million series B in 2024 and an $84-million series A extension in 2022, with backing from Novartis, Bristol Myers Squibb, Eli Lilly and Merck & Co.New CEO at argenxFollowing the first approvals and launches of argenx's flagship autoimmune drug, co-founder Tim Van Hauwermeiren is stepping down as CEO, handing the leadership baton to Chief Operating Officer (COO) Karen Massey.The company first secured FDA approval for intravenous Vyvgart in late 2021 for generalised myasthenia gravis (gMG), followed by approvals for the FcRn inhibitor's subcutaneous counterpart, Vyvgart Hytrulo, for gMG in 2023 and chronic inflammatory demyelinating polyneuropathy a year after that.However, hopes of securing another indication for its sole marketed drug were dashed last month after the company said it would discontinue Phase III studies in thyroid eye disease due to futility."Karen has delivered exceptional impact since joining argenx three years ago — accelerating Vyvgart's launch [and] building a future-proof commercial engine," said Van Hauwermeiren, who will transition to non-executive director and chairman of the board. "As chairman, I will be a sounding board to Karen and the team on long-term strategy, stay close to the innovation mission by engaging with the external ecosystem and lead the board's evolution to facilitate our next phase of growth."Massey joined argenx as COO in early 2023 after nearly a decade at Genentech, where she served as senior vice president of product development and global clinical operations. She started her biopharmaceutical career in marketing at Pfizer.Moderna's mRNA flu shotRiding the rollercoaster of COVID-19 vaccine triumphs and the lows of a post-pandemic sales slump, Moderna said Monday that the company is moving on to its next infectious disease goal and submitted filings for its experimental mRNA-1010 seasonal flu vaccine to regulators in the US, EU, Canada and Australia."The issue of vaccine mismatch due to virus mutations has long worried influenza experts and, as we have seen this flu season, can lead to a heightened public health burden," CEO Stéphane Bancel said. "The agility and flexibility of mRNA technology offer the potential to more closely match evolving strains and more effectively respond to one of the world's most persistent respiratory threats."The applications follow positive Phase III results in adults aged 50 and older. Compared to a licensed standard-dose seasonal influenza jab, mRNA-1010 achieved a relative vaccine efficacy against influenza illness of 26.6% in the P304 trial, rising to 27.4% in those aged 65 years and older.The company last year withdrew its FDA application for mRNA-1083, a combination influenza/COVID-19 candidate, after regulators requested additional Phase III flu efficacy data.More recently, Moderna was the recipient of a $54.3-million award from the Coalition for Epidemic Preparedness Innovations, which is funding late-stage development of the company's H5 avian influenza vaccine, mRNA-1018.

Phase 3VaccineDrug ApprovalExecutive ChangeClinical Result

15 Dec 2025

·www.fiercepharma.com

Argenx permanently grounds studies of high-flying Vyvgart in thyroid eye disease

Argenx is discontinuing its late-stage UplighTED studies of subcutaneous efgartigimod in adults with moderate to severe thyroid eye disease. While argenx has been able to demonstrate the merit of its FcRn drug Vyvgart in multiple autoimmune indications, not every shot in the clinic is destined to land.Now, facing that fact in thyroid eye disease (TED), argenx is walking away from a set of trials.Argenx is discontinuing its late-stage UplighTED studies of subcutaneous efgartigimod in adults with moderate to severe TED, the Dutch biopharma announced Monday. Efgartigimod is the generic name for Vyvgart, which is approved both as an infusion and as an injectable under the brand name Vyvgart Hytrulo, with the latter being the format tested in argenx’s study.The drugmaker is calling it quits on the Vyvgart Hytrulo TED program following a recommendation from an independent data monitoring committee, which urged argenx to stop the trials for futility after reviewing data at a preset interim analysis.There was a small silver lining insofar as Vyvgart Hytrulo’s safety and tolerability looked favorable in the trials, with no new safety flags cropping up, argenx pointed out. The company’s stock was down more than 5% in morning trading Dec. 15.The futility evaluation came at the studies’ 24-week mark, argenx explained. The company says it plans to parse through the data, once available, so it can better understand the “studies’ outcome and uncover key biological insights that may inform future research in TED.”The company noted that it will share the results at an upcoming medical meeting, as well. TED, an autoimmune disease affecting the eye socket, can cause muscles that control the eye and fat behind the organ to grow abnormally, and it can also lead to orbital inflammation. This can in turn cause proptosis (when the eyes bulge from their natural position), diplopia (double vision) or, in severe cases, vision loss, argenx explained in its release.The company’s UplighTED studies specifically looked at TED patients with the autoimmune thyroid conditions Graves’ disease or Hashimoto’s thyroiditis. The primary endpoint of the studies—which pitted Vyvgart Hytrulo against placebo—concerned the percentage of patients classified as “proptosis responders” at Week 24, argenx said.The trials also looked at secondary metrics such as the change in proptosis measurement from baseline, change in total score on a quality-of-life measure known as Graves’ Orbitopathy Quality of Life, and the percentage of trial participants whose diplopia had resolved, all at 24 weeks.“We are disappointed the studies did not meet our desired outcome and we especially empathize with patients who are living with TED and seeking new therapies for this challenging disease,” Luc Truyen, M.D., Ph.D., argenx’s chief medical officer, said in a statement. “We had pre-planned this futility analysis as it provides a meaningful interim evaluation of observed patient outcomes and enables us to responsibly evaluate the study’s future likelihood of success.”Since the original approval of infused Vyvgart in generalized myasthenia gravis (gMG) in late 2021, argenx has largely made good on its thesis that the asset has potential in a range of autoimmune diseases. For its part, Vyvgart Hyrulo—the drug’s subcutaneous formulation—is broadly approved in gMG and chronic inflammatory demyelinating polyneuropathy around the world, and the drug also boasts a nod to treat primary immune thrombocytopenia in Japan. In the clinic, argenx is trialing efgartigimod in numerous autoimmune diseases, from ocular myasthenia gravis and myositis to Sjogren’s disease and systemic sclerosis, among other potential indications.In the nearer term, the Dutch drugmaker is aiming for an FDA nod for both subQ and infused Vyvgart in the subset of gMG patients who are seronegative, meaning their condition lacks detectable levels of certain antibodies that are often characteristic of the disease. With results from a positive phase 3 seronegative trial in hand, argenx has said it plans to file for an FDA review in the indication by the end of 2025.

Phase 3Drug ApprovalClinical Result

100 Deals associated with Efgartigimod Alfa

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KEGG	Wiki	ATC	Drug Bank
-	Efgartigimod Alfa	-	DB15270

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	European Union	argenx US, Inc.	20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Iceland	argenx US, Inc.	20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Liechtenstein	argenx US, Inc.	20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Norway	argenx US, Inc.	20 Jun 2025
Chronic idiopathic thrombocytopenic purpura	Japan	argenx SE	26 Mar 2024
Purpura, Thrombocytopenic, Idiopathic	Japan	argenx SE	26 Mar 2024
Myasthenia Gravis	United States	argenx BV	17 Dec 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Sjögren's syndrome	Phase 3	United States	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	China	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Japan	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Argentina	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Australia	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Austria	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Belgium	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Bulgaria	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Canada	argenx SE	15 Jan 2025
Primary Sjögren's syndrome	Phase 3	Chile	argenx SE	15 Jan 2025

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04188379 (ADVANCE IV, ASH2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic	134	Efgartigimod treated	fxhkasanxz(asbqdvdcqq) = jlednwyvcf bocesdgusk (bgjzmnckxa ) View more	Positive	06 Dec 2025
				Placebo treated, initiated efgartigimod	fxhkasanxz(asbqdvdcqq) = duqwuqynhp bocesdgusk (bgjzmnckxa ) View more
NCT05810948 (ASN2025)	Phase 2	Lupus Nephritis	72	Efgartigimod (Lupus Nephritis)	nakhhavhqt(qrddsqpupm) = vawkslrddb wogzzccxtk (tdbnwxijkj )	Positive	07 Nov 2025
				Placebo (Lupus Nephritis)	jrjtdpfeul(hmuxkgjjrz) = vewrpnqwhk xttfwixbmq (jyxuhontry ) View more
NCT05817669 (RHO, ACR2025)	Phase 2	Sjogren's Syndrome	34	Efgartigimod	xoelwdcbfe(ckbswddrgz) = jeqjmvuiwu znciiauhqq (szjsyotyqe ) View more	Positive	24 Oct 2025
				Placebo	xoelwdcbfe(ckbswddrgz) = hseshxbbng znciiauhqq (szjsyotyqe ) View more
NCT05918978 (POTS, CTgov)	Phase 2	Postural Orthostatic Tachycardia Syndrome \| Post Acute COVID 19 Syndrome	33	Efgartigimod (Efgartigimod-Efgartigimod)	umgnzlezgf = qnfsqymsxp egvrkjrosf (ombttzdxdr, maitgpkojl - cduixesiet) View more	-	23 Oct 2025
				Placebo+Efgartigimod (Placebo-Efgartigimod)	umgnzlezgf = otcxembfog egvrkjrosf (ombttzdxdr, bsjstuuxgf - brbmezimwf) View more
NCT06298552 (ADAPT SERON, NEWS) Manual	Phase 3	Myasthenia Gravis	29	艾加莫德	ykhxdzucze(lxchtlfiky) = 研究达到主要终点（p=0.0068），与安慰剂相比，接受艾加莫德治疗的AChR抗体阴性gMG患者在重症肌无力日常活动评分（MG-ADL）上表现出具有显著统计学意义和临床意义的改善 bvvdgldfew (djumcaceyb ) Met	Positive	25 Aug 2025
				安慰剂
NCT05817669 (RHO, CTgov)	Phase 2	Spinocerebellar Ataxias \| Primary Sjögren's syndrome	34	Efgartigimod (Efgartigimod)	anigiflafe = pdtfirsgkv rxdyeuasvn (tvtntluexa, dmomdjmyop - wxyxopxerj) View more	-	18 Jul 2025
				placebo+efgartigimod (Placebo)	anigiflafe = vmqvvicbet rxdyeuasvn (tvtntluexa, jfljdvhyum - wnrfescgqs) View more
NCT05817669 (RHO, EULAR2025)	Phase 2	-	34	Efgartigimod	xjywwpquee(rjeywchjsh) = fcsmfflwqo zjfuwaxeeh (zlbmvpvvxl ) View more	Positive	11 Jun 2025
				Placebo	xjywwpquee(rjeywchjsh) = oeqvtabamd zjfuwaxeeh (zlbmvpvvxl ) View more
NCT05633407 (POTS, CTgov)	Phase 2	Postural Orthostatic Tachycardia Syndrome \| Post Acute COVID 19 Syndrome	53	Efgartigimod (Efgartigimod)	rjkzddhqwj(apjijdwoty) = vnlwvpppig sqhvclzdls (ktutywhoaf, 15.2541) View more	-	23 May 2025
				Placebo (Placebo)	rjkzddhqwj(apjijdwoty) = rsgefkuird sqhvclzdls (ktutywhoaf, 17.2963) View more
NCT04188379 (ADVANCE IV, EHA2025)	Phase 3	Purpura, Thrombocytopenic, Idiopathic Maintenance	131	Efgartigimod IV 10 mg/kg	zvudasdwbq(pqkfryukbz) = xesppiramc itsznpxcnf (iedyumiigb, ±3.8) View more	Positive	14 May 2025
				Placebo	zvudasdwbq(pqkfryukbz) = yxbpbhnnuy itsznpxcnf (iedyumiigb, ±2.0) View more
NCT04980495 (ADAPT NXT, Neurology \| AAN2025) Manual	Phase 3	Myasthenia Gravis	69	efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles) (Part A)	kexamyxiqs(wqelfdesog) = ebgitswcgd nysomljktl (kqfkwrlydw, -6.5 to -3.8) View more	Positive	07 Apr 2025
				efgartigimod Q2W (Part A)	kexamyxiqs(wqelfdesog) = vzzahqcdnd nysomljktl (kqfkwrlydw, -5.4 to -3.8) View more

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