CD38 inhibitors(Lymphocyte differentiation antigen CD38 inhibitors), ADCC(Antibody-dependent cell-mediated cytotoxicity (ADCC) effects), Antibody-dependent cellular phagocytosis (ADCP) effects

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [4]

Active Indication

Multiple MyelomaIdiopathic Membranous GlomerulonephritisGlomerulonephritis, IGA+ [7]

Inactive Indication-

Originator Organization

MorphoSys AG

Active Organization

Biogen, Inc.

TJ Biopharma Hangzhou Co Ltd

Human Immunology Biosciences, Inc.

+ [3]

Inactive Organization-

License Organization

Human Immunology Biosciences, Inc.

Biogen, Inc.I-MAB Biopharma Co., Ltd.

+ [4]

Drug Highest PhaseNDA/BLA

First Approval Date-

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Sequence Code 616722725H

Source: *****

Sequence Code 616722726L

Source: *****

Clinical Trials associated with Felzartamab

NCT07219043

/ Not yet recruitingPhase 2

A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants With Late Isolated Microvascular Inflammation (MVI)

In this study, researchers will learn more about a drug called felzartamab in people who have received a kidney transplant and later developed a condition called microvascular inflammation (MVI). MVI is a type of injury to small blood vessels in the transplanted kidney and may be a sign of rejection by the body. It can lead to serious kidney problems over time.
The main goal of the study is to learn about the effect felzartamab has on kidney inflammation. The main question researchers want to answer is:
• How many participants have no signs of active inflammation in the kidneys after 24 weeks of treatment with felzartamab?
Researchers will also study how felzartamab affects kidney function, immune activity, and overall health. They will monitor safety through kidney biopsies, lab tests, and by recording adverse events throughout the study.
Adverse events are unwanted health problems that may or may not be caused by the study drug.
The study will be done in 2 parts as follows:
* Participants will be randomly assigned to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* In Part A, participants will receive their assigned drug for 24 weeks. Neither the researchers nor the participants will know who is receiving felzartamab or placebo.
* Part B will last another 28 weeks. All participants will receive felzartamab and both participants and researchers will know this.
* All treatments will be given by intravenous (IV) infusion at the study site.
* Participants will have kidney biopsies at the start of the study, at 24 weeks, and at 52 weeks to help measure changes in inflammation.
* Participants will stay in the study for about 1 year.

Start Date17 Nov 2025

Sponsor / Collaborator

Biogen, Inc.

NCT06962800

/ RecruitingPhase 3

An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.
Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.
In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.
The main question that researchers want to answer is:
* How many participants achieve a complete response after 104 weeks of treatment?
* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.
Researchers will also learn about:
* How long it takes before the participants' disease gets worse
* How long the participants' urine protein levels stay low
* How many participants develop antibodies against felzartamab in the blood?
* How many participants achieve a complete response after 76 weeks of treatment
* How many participants have medical problems during the study
* How felzartamab is processed by the body
* How felzartamab affects participants' tiredness and overall physical health
The study will be done as follows:
* Participants will be screened to check if they can join the study. This may take up to 42 days.
* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.
* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.
* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.
* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Start Date22 May 2025

Sponsor / Collaborator

Biogen, Inc.

NCT06935357

/ RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.
The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:
• How much does the amount of protein in the urine change from the start of the study to Week 36?
Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.
The study will be done as follows:
* Participants will be screened to check if they can join the study.
* Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
* Neither the researchers nor the participants will know what the participants will receive.
* Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.
* Afterwards, participants will enter a follow-up period which will last 80 weeks.
* In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Start Date08 May 2025

Sponsor / Collaborator

Biogen, Inc.

[+1]

100 Clinical Results associated with Felzartamab

100 Translational Medicine associated with Felzartamab

100 Patents (Medical) associated with Felzartamab

Literatures (Medical) associated with Felzartamab

01 Nov 2025·KIDNEY INTERNATIONAL

Felzartamab: a magic bullet to treat microvascular rejection?

Article

Author: Thaunat, Olivier ; Colvin, Robert B

01 Oct 2025·KIDNEY INTERNATIONAL

Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy

Article

Author: Lafayette, Richard ; Manser, Paul T ; Faulhaber, Nicola ; Kräft, Tabea ; Barbour, Sean J ; Shah, Millie ; Floege, Jürgen ; Thakur, Anjali ; Kivman, Lisa ; Härtle, Stefan ; Schwartz, Brian ; Barratt, Jonathan ; Patel, Uptal D

INTRODUCTION:

Felzartamab is a fully human anti-CD38 monoclonal antibody under investigation for treatment of IgA nephropathy (IgAN). IGNAZ (NCT05065970) is a randomized, double blind, placebo-controlled Phase 2a study that assessed the efficacy and safety of felzartamab in 54 patients with biopsy-confirmed IgAN despite maximal renin angiotensin system blockade.

METHODS:

In part 1, patients were randomized in the 6-month treatment period to receive intravenous placebo (12 patients) or felzartamab in three arms: two doses in 15 days (2-dose, 12 patients), five doses in 2 months (5-dose, 11 patients), or nine doses in five months (9-dose, 13 patients). In part 2, six Japanese patients received the felzartamab 9-dose schedule open-label. Follow-up in parts 1 and 2 was 24 and 12 months, respectively, after the first dose. The primary endpoint was change in proteinuria (urine protein to creatinine ratio [UPCR]) at nine months.

RESULTS:

Treatment with felzartamab versus placebo led to rapid (within 3-6 months) reduction in least-squares mean UPCR sustained at nine months (placebo, -5.7%; 2-dose, -12.5%; 5-dose, -12.8%; 9-dose, -29.5%; part 2, -44.8%) and at 18 months after ending treatment (24 months), particularly in the 9-dose arm (-44.5%). Mean decreases in estimated glomerular filtration rate were lower with felzartamab than with placebo through 24 months in part 1 and 12 months in part 2. Felzartamab safety was consistent with prior observations; adverse events were predominantly grade 1 or 2.

CONCLUSIONS:

Treatment with felzartamab results in sustained reduction of proteinuria, suggesting disease improvement. Further evidence is needed to understand the impact of felzartamab on preservation of kidney function in high-risk patients with IgAN.

TRIAL REGISTRATION:

Registered at ClinicalTrials.gov with study number NCT05065970.

01 Aug 2025·NEPHROLOGY DIALYSIS TRANSPLANTATION

Antibody-mediated rejection—treatment standard

Review

Author: Thaunat, Olivier ; Diebold, Matthias ; Naesens, Maarten ; Budde, Klemens ; Viklicky, Ondrej ; Böhmig, Georg A ; Rostaing, Lionel

ABSTRACT:

Antibody-mediated rejection (AMR) remains a major cause of graft failure, with significant health and economic burden. Despite being recognized >25 years ago, AMR treatment remains unstandardized, and no therapy has gained robust regulatory approval. While uncontrolled series have shown promise, few well-designed trials exist, with most yielding negative results. In the absence of strong trial data, a Transplantation Society expert consensus recommended potential treatment options with low levels of evidence, tailored to clinical phenotypes. Here, we re-evaluate the current evidence for AMR treatment decisions. We conclude that steroids, rituximab, bortezomib, and interleukin-6 (IL-6) antagonists lack sufficiently robust evidence to support their use in AMR. For early AMR, antibody depletion using immunoadsorption could be considered as an alternative to plasmapheresis. High-dose intravenous immunoglobulin (IVIG) may be added, though the supporting evidence remains limited. While previous trials primarily targeted the cause of AMR, recent data on the successful reversal of AMR activity by CD38 antibodies—particularly recent phase 2 trial results—suggest that targeting the cellular inflammation resulting from antibody binding to the endothelium could be a rational approach. Along these lines, in severe early AMR, complement inhibition may also be an option. Ongoing phase 2 trials evaluating prolonged courses of high-dose IVIG, the neonatal Fc receptor blocker efgartigimod, the tyrosine kinase inhibitor fostamatinib, and the complement inhibitor BIVV020, along with phase 3 trials of the anti-IL-6 receptor antibody tocilizumab and the CD38 antibody felzartamab, offer hope for effective, approved therapies targeting different aspects of AMR pathobiology.

102

News (Medical) associated with Felzartamab

24 Oct 2025

·www.fiercebiotech.com

Biogen beefs up immunology pipeline with $1B deal for Vanqua\'s preclinical C5aR1 antagonist

Biogen’s current immunology pipeline is led by dapirolizumab pegol, a UCB-partnered anti-CD40L drug that notched a phase 3 win in systemic lupus erythematosus last year.\n Biogen plans to beef up its early-stage immunology pipeline by handing over $70 million in upfront cash for the rights to Vanqua Bio’s preclinical C5aR1 antagonist.Biogen described C5aR1 as a “well-validated target involved in neutrophil-mediated inflammation.” The biopharma is banking on applying the oral C5aR1 antagonist’s mechanism across “multiple immune-mediated diseases” with an ambition of entering the clinic in 2027.C5aR1 plays an important role in the immune cascade that causes tissue inflammation, particularly in neutrophil-mediated conditions. There’s an obvious overlap with Biogen’s own izastobart, an antibody directed against C5aR1 the company has been evaluating in a phase 1 study.Beyond the $70 million upfront payment from this morning’s deal, Chicago-based Vanqua is in line for up to $990 million in potential development, regulatory, commercial and sales milestone payments as well as tiered royalties should a drug make it to market.“This agreement reflects our strong commitment to building a comprehensive immunology pipeline with a strategic focus on both innate and adaptive immune pathways,” Biogen\'s head of research Jane Grogan, Ph.D., said in this morning’s release.“C5aR1 is a well-validated target involved in neutrophil-mediated inflammation, which plays a central role across a range of inflammatory disorders,” Grogan added. “Advancing this program enables us to deepen our scientific and clinical focus in immunological diseases where we believe Biogen can make a meaningful difference for patients.” Biogen’s current immunology pipeline is led by dapirolizumab pegol, a UCB-partnered anti-CD40L drug that notched a phase 3 win in systemic lupus erythematosus last year. Also in late-stage development for lupus is the anti-BDCA2 antibody litifilimab, along with felzartamab, a monoclonal antibody designed to deplete CD38+ plasma cells, which is being evaluated for antibody-mediated rejection and various types of nephropathy.Both felzartamab and the phase 1-stage izastobart were acquired as part of Biogen’s buyout of Human Immunology Biosciences (HI-Bio) last year.“Biogen’s scale, development rigor, and global commercialization capabilities make them uniquely positioned to advance this compound for patients with inflammatory disorders,” Vanqua CEO Jim Sullivan, Ph.D., said in today\'s release.“The discovery of a highly differentiated C5aR1 inhibitor validates the small molecule drug discovery capabilities of the Vanqua team,” Sullivan added. “Furthermore, this transaction allows Vanqua to remain focused on our CNS pipeline while ensuring that this program can be developed to its full potential.”William Blair analysts said the deal with Vanqua “adds an intriguing, albeit early, preclinical-stage asset to Biogen’s growing immunology pipeline aligned with its therapeutic pipeline strategy.” “We continue to see developing excitement about Biogen’s late-stage neurology and immunology pipeline, which may provide a longer-term solution to the eroding MS franchise and slower-than-anticipated Leqembi launch,” the analysts added in an Oct. 24 note.The deal follows Biogen’s reorganization at the beginning of the year that included layoffs and a shift to focus on external opportunities. Shortly after announcing the restructure, Biogen paid Stoke Therapeutics $165 million upfront for ex-U.S. rights to a phase 3-ready molecule that could become the first disease-modifying treatment for Dravet syndrome.Since then, the company has abandoned work on adeno-associated virus gene therapies while penning a big biobucks deal with RNAi-focused City Therapeutics and buying drug delivery specialist Alcyone Therapeutics.

$Biogen beefs up immunology pipeline with $1B deal for Vanqua\'s preclinical C5aR1 antagonist$

ImmunotherapyPhase 1Phase 3Acquisition

24 Oct 2025

·firstwordpharma.com

Biogen buys into Vanqua's preclinical C5aR1 asset for up to $1.1B

Biogen inked a deal worth up to $1.1 billion with Vanqua Bio, securing exclusive global rights to a preclinical oral C5aR1 antagonist, the companies announced Friday. The agreement adds another inflammation-focused asset to Biogen's growing immunology portfolio.C5aR1 plays a key role in driving critical components of the immune cascade involved in tissue inflammation, particularly in neutrophil-mediated conditions. In preclinical testing, the compound blocked complement activation of pathogenic immune cells and showed a safety profile supportive of clinical advancement, according to the companies."C5aR1 is a well-validated target involved in neutrophil-mediated inflammation, which plays a central role across a range of inflammatory disorders," said Jane Grogan, Biogen's head of research. "This agreement reflects our strong commitment to building a comprehensive immunology pipeline with a strategic focus on both innate and adaptive immune pathways."IND planned for 2027Under the deal, Biogen will pay Vanqua $70 million upfront and up to $990 million in potential milestones, along with tiered royalties on future sales. Biogen will assume responsibility for all future development, manufacturing and commercialisation efforts, and said it expects to file an IND application in 2027 if preclinical results continue to support the programme.The deal is in line with Biogen's shift in research strategy, confirmed early this year, that includes a newly prioritised preclinical portfolio and a focus on external collaborations. Some transactions over the last year and half include its $1.15-billion acquisition of Human Immunology Biosciences (HI-Bio) and collaboration on RNAi therapies with City Therapeutics potentially worth over $1 billion.Biogen's immunology pipeline now includes six Phase III programmes; namely, dapirolizumab pegol and litifilimab for lupus, and felzartamab, acquired through the HI-Bio deal, for nephropathy and antibody-mediated rejection.

ImmunotherapyAcquisitionPhase 3License out/inClinical Result

24 Oct 2025

·www.biospace.com

Biogen Grows Immunology Pipeline With Vanqua’s Anti-Inflammatory Molecule

iStock, Veronique D The $70 million upfront deal adds to a portfolio of drugs Biogen has been growing in various immunological conditions since 2024. Biogen has licensed Vanqua Bio’s preclinical oral C5aR1 antagonist in a bid to pump up its immunology pipeline. Under the terms of the deal, Vanqua will receive a $70 million upfront payment, with $990 million in developmental, regulatory, commercial and sales milestone payments on the line, according to an announcement Friday. In exchange, Biogen will receive the exclusive worldwide rights to Vanqua’s orally available C5aR1 program. C5aR1 is a cell membrane protein involved in the body’s complement system and the immune cascade involved in tissue inflammation. The companies did not name specific indications that Biogen will pursue with the molecule. According to analysts at William Blair, preclinical safety and tolerability could point Biogen toward an investigational new drug application for the program in 2027. “Today’s deal with Vanqua adds an intriguing, albeit early, preclinical-stage asset to Biogen’s growing immunology pipeline aligned with its therapeutic pipeline strategy,” the analysts wrote in a note to investors Friday. “Biogen’s stock has no doubt been a tough run, and other large-cap peers have navigated loss of exclusivity better than Biogen,” the William Blair analysts continued, though pointing out the September approval of a subcutaneous version of its Alzheimer’s drug Leqembi gives the company positive momentum. Biogen has been relatively quiet on the dealmaking front in 2025, despite facing pressure to use its pocketbook to shore up a flagging share price earlier this year. The deal with Vanqua is the first pipeline acquisition the company has made this year. The only pipeline-related deal Biogen has made this year was getting $250 million from Royalty Pharma to help develop an investigational lupus antibody, currently in Phase III trials. Biogen has already been working on targeting C5aR1 with its antibody izastobart in Phase I trials, being tested for a variety of autoimmune conditions. Biogen got izastobart when it bought Human Immunology Biosciences, also known as Hi-Bio, in 2024 for $1.15 billion upfront, also scoring Hi-Bio’s lead molecule, felzartamab, an anti-CD38 monolonal antibody to treat “a broad range of immune-mediated diseases.” Signing away its C5aR1 program will help the Chicago-based Vanqua adjust its priorities. “This transaction allows Vanqua to remain focused on our CNS pipeline while ensuring that this program can be developed to its full potential,” CEO Jim Sullivan said in the statement announcing the deal. With its inflammatory disease portfolio now in Biogen’s hands, the rest of Vanqua’s pipeline focuses on neurodegenerative diseases like Parkinson’s, dementia with Lewy Bodies, Alzheimer’s and other undisclosed diseases.

ImmunotherapyPhase 1AcquisitionPhase 3Phase 2

100 Deals associated with Felzartamab

External Link

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Myeloma	NDA/BLA	China	TJ Biopharma Hangzhou Co Ltd	08 Jan 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	United States	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	China	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Argentina	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Australia	Biogen, Inc.	22 May 2025
Idiopathic Membranous Glomerulonephritis	Phase 3	Brazil	Biogen, Inc.	22 May 2025
Glomerulonephritis, IGA	Phase 3	United States	TJ Biopharma Hangzhou Co Ltd	28 Mar 2025
Glomerulonephritis, IGA	Phase 3	China	TJ Biopharma Hangzhou Co Ltd	28 Mar 2025
Glomerulonephritis, IGA	Phase 3	Argentina	TJ Biopharma Hangzhou Co Ltd	28 Mar 2025
Glomerulonephritis, IGA	Phase 3	Australia	TJ Biopharma Hangzhou Co Ltd	28 Mar 2025

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05065970 (IGNAZ, ASN2024) Manual	Phase 2	Glomerulonephritis, IGA	54	Felzartamab (2 doses in 15 days)	lblxhdouyw(kcvdjyrfty) = Treatment with felzartamab led to rapid, clinically meaningful reductions in UPCR vs PBO, with the greatest effect in the M3 arm. nhkiuhecra (csxzpwbgmm ) View more	Positive	26 Oct 2024
				Felzartamab (5 doses in 2 months)
NCT04145440 (M-PLACE, Pubmed) Manual	Phase 1/2	Idiopathic Membranous Glomerulonephritis anti-Phospholipase A2 receptor autoantibody-positive	31	Felzartamab 16 mg/kg	tczejyjizl(clxntiksas) = xyccrecqub jimhllqbkr (cyyiquubzh ) View more	Positive	20 Jun 2024
				Felzartamab 16 mg/kg (newly diagnosed or relapsed PMN)	zwaucqwcgg(hkwddsqyye) = negszhlqqx wgqxbtlich (knszhnqmzi )
NCT05021484 (NEWS) Manual	Phase 2	Renal transplant rejection	22	Felzartamab	mzhtppushg(bvbpldrwsw) = felzartamab showing an acceptable safety profile and most adverse events being mild or moderate. ufbcscvsdt (wpxzywcyvm )	Positive	27 May 2024
				Placebo
NCT05065970 (IGNAZ, PRNewswire) Manual	Phase 2	Glomerulonephritis, IGA	54	Felzartamab	ditqnkazkb(aoyrivritc) = uoohwnertd uittoskqxx (rvdnlhvqme )	Positive	24 May 2024
				Placebo	-
NCT04145440 (M-PLACE, ASN2023) Manual	Phase 1/2	Idiopathic Membranous Glomerulonephritis First line	31	Felzartamab	znvszbhpwg(iqtemzrjgk) = qlzrlhqjbt thlcsufzck (tlgnkrslod ) View more	Positive	02 Nov 2023
				Felzartamab (newly diagnosed or relapsed patients)	qnlzckxxcm(rmayeastme) = lzqloyvfwa gsrtbslaso (lmgjhjhino ) View more
NCT04145440 (M-PLACE, ASN2022)	Phase 1/2	Glomerulonephritis, Membranous anti-PLA2R Abs	31	Felzartamab (MOR202) 16 mg/kg	velammmnwe(sxbnknyqov) = nxfnropsdb dqpwnatoku (wxjeossffq )	Positive	05 Nov 2022
NCT01421186 (ASCO 12017 \| ASCO 22017) Manual	Phase 1/2	Multiple Myeloma	44	dexamethasone+MOR202	dvctmpfdeo(nwthouxoap) = The MTD of MOR202 was not reached uepmnvojnq (mejeolvqhn )	Positive	05 Jun 2017
				dexamethasone+lenalidomide+MOR202

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