Delving into the Latest Updates on Bimekizumab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

Anti-IL-17-mAb-UCB, Anti-IL-17-monoclonal-antibody-UCB, Anti-interleukin-17-monoclonal-antibody-UCB

+ [14]

Target

IL-17A x IL-17F

Action

inhibitors

Mechanism

IL-17A inhibitors(Interleukin 17A inhibitors), IL-17F inhibitors(Interleukin-17F inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases+ [1]

Active Indication

Hidradenitis SuppurativaAnkylosing SpondylitisAxial Spondyloarthritis+ [9]

Inactive Indication

Influenza, HumanRheumatoid Arthritis

Originator Organization

UCB SA

Active Organization

UCB Pharma SAUCB Biopharma SRL

UCB SA

+ [6]

Inactive Organization

UCB Celltech

Drug Highest PhaseApproved

First Approval Date

European Union (20 Aug 2021),

Arthritis, PsoriaticPlaque psoriasis

Regulation-

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Structure/Sequence

Sequence Code 9975662H

Source: *****

Sequence Code 13372170L

Source: *****

Psoriasis is a chronic inflammatory condition driven by a complex interplay between heritable and microenvironmental factors. Genome-wide heritability for psoriasis (PsO) is estimated at up to 50%. Although bearing genetic susceptibility at birth, most patients will remain disease free for years until an exposomal trigger activates the immunological pathway that leads to the first disease flare. In rare patients, the first flare is an isolated event, but in most patients it will evolve into a chronically relapsing-remitting disease characterized by lasting lesions and recurrent flares. Primary objective is to compare efficacy of bimekizumab versus topical corticosteroids on psoriasis clinical disease activity, assessed by PGA, at week 16 and week 24.
Patients will be randomized 1:1 to receive either 320mg bimekizumab at weeks 0 (W0), W4, W8 and W12, or clobetasol ointment for 2 to 4 weeks until complete clearance of the lesion. After a maximum of 4 weeks topical clobetasol will be applied twice weekly on the site of lesion until week 16 then stopped. Patients will not receive active treatment between week 16-24. Between week 24-96 patients that flare can receive continuous topical clobetasol if needed. These patients will be considered non-responders at subsequent timepoints for the main analysis. If the patients worsen their psoriasis under the treatments given during the study and progress to moderate or severe psoriasis (PASI 10 and above) they will end their participation to the study to receive a treatment adapted to the new severity of their psoriasis. The patients will be referred to their dermatologist to receive the actual standard of care adapted to their new condition.
During the study, the following assessments will be performed and samples will be collected

Start Date01 Apr 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Nice

NCT06668181

/ RecruitingPhase 3

Open-Label, Single-Arm Trial to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants From 2 to Less Than 18 Years of Age With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-Related Arthritis (Including Juvenile-Onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis

The purpose of this study is to assess plasma bimekizumab concentrations following subcutaneous (sc) bimekizumab administration.

Start Date11 Mar 2025

Sponsor / Collaborator

UCB Biopharma SRL

100 Clinical Results associated with Bimekizumab

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100 Translational Medicine associated with Bimekizumab

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100 Patents (Medical) associated with Bimekizumab

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283

Literatures (Medical) associated with Bimekizumab

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Bimekizumab for the treatment of moderate to severe psoriasis: a real-world experience over 52 weeks from two Italian dermatology clinics

Article

Author: Bianchi, L. ; Loconsole, F. ; Gaeta Shumak, R. ; Mortato, E. ; Campione, E. ; Rivieccio, Antonia ; Lanna, C. ; Borselli, C. ; Artosi, F. ; Lambiase, S. ; Compagnucci, I.

PURPOSE:

Psoriasis is a chronic, immune-mediated inflammatory skin condition marked by erythematous, scaly plaques. This retrospective observational study evaluated the long-term efficacy and safety of bimekizumab, a dual IL-17A and IL-17F inhibitor, in treating moderate to severe plaque psoriasis in 56 patients across two dermatology clinics in Italy.

MATERIALS AND METHODS:

Adult participants with a baseline Psoriasis Area and Severity Index (PASI) >10, or <10 with sensitive area involvement, were followed for 16 to 52 weeks. Clinical outcomes were measured by PASI 75, 90, and 100 responses and Dermatology Life Quality Index (DLQI) scores at 4, 16, 36, and 52 weeks.

RESULTS:

At week 16, 97.5% of patients achieved PASI 75, 76.7% reached PASI 90, and 66% attained PASI 100. By week 52, 91.5% achieved PASI 90 and 85.1% reached PASI 100, with 95.7% reporting a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating minimal impact on daily life. The study found similar efficacy across bio-naïve and bio-experienced groups, and between normal-weight and obese patients, without statistically significant differences. The safety profile was consistent with previous trials, with oral candidiasis as the most frequent adverse event (21%).

CONCLUSIONS:

These findings support the efficacy and tolerability of bimekizumab for long-term psoriasis management.

26 Mar 2025·CLINICAL AND EXPERIMENTAL DERMATOLOGY

The risk of candidiasis during treatment with bimekizumab for the management of plaque psoriasis: a 16-week multicentre real-world experience – IL PSO (Italian Landscape Psoriasis)

Article

Author: Megna, Matteo

Anti-interleukin 17 use has been associated with a higher risk of candidiasis, as this cytokine is involved in maintaining mucosal barriers and orchestrating immune responses to fungal pathogens. We performed a real-life retrospective multicentre study aiming to assess the risk of candidiasis in patients undergoing treatment with bimekizumab at labelled dosage for psoriasis, for at least 16 weeks.

18 Mar 2025·BRITISH JOURNAL OF DERMATOLOGY

The roles of interleukin (IL)-17A and IL-17F in hidradenitis suppurativa pathogenesis: evidence from human in vitro preclinical experiments and clinical samples

Article

Author: Shaw, Stevan ; Page, Matthew ; Edwards, Hannah ; Rastrick, Joseph ; Le Friec, Gaëlle ; Manghera, Avneet ; Ferecskó, Alex S

Abstract:

Background:

Hidradenitis suppurativa (HS) is a chronic relapsing inflammatory skin disease associated with significant comorbidities and poor quality of life. Despite uncertainty about pathways driving inflammation in HS lesions, the cytokines interleukin (IL)-17A and IL-17F have been shown to be upregulated in patients with HS. Previous studies have demonstrated that the monoclonal IgG1 antibody bimekizumab selectively inhibits IL-17F in addition to IL-17A.

Objectives:

To further investigate the roles of IL-17A and IL-17F in HS pathogenesis.

Methods:

RNA sequencing (RNAseq) was conducted on skin biopsies taken at baseline and after treatment at week 12 of a phase II proof-of-concept study of bimekizumab in patients with moderate-to-severe HS. Differentially expressed genes were identified between baseline lesional and nonlesional samples and between lesional samples before and after bimekizumab treatment, to describe molecular disease mechanisms and treatment effect. Human hair follicular keratinocytes (HHFK) were cultured and treated with a supernatant of stimulated T helper (Th)17 cells in combination with anti-IL-17A, anti-IL-17F, anti-IL-17A and anti-IL-17F, or IgG control antibodies. Total mRNA was analysed by RNAseq. Cellular supernatants from the stimulated HHFKs were used as a source of Th17-induced chemoattractants in neutrophil chemotaxis assays.

Results:

RNAseq revealed that the most prominently upregulated genes in HS lesions included those associated with neutrophil biology. Bimekizumab treatment resulted in reduced expression of these genes. The extent of reduction in gene expression was dependent on achieving HiSCR50 (≥ 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count). In vitro dual inhibition of IL-17A and IL-17F had greater attenuation of Th17-induced HS-associated genes and neutrophil migration in HHFKs vs. IL-17A or IL-17F inhibition alone. In situ hybridization found that IL-17A- and IL-17F-producing cells in HS lesions can lack the IL-23 receptor and IL-1β could induce IL-23-independent IL-17F expression in vitro. Furthermore, mucosal-associated invariant cells in HS tunnels expressed IL-17F and IL-1 receptor type 1. IL-1β-, IL-17A- and IL-17F-expressing cells were found to be co-localized in HS lesions.

Conclusions:

These data support the hypothesis that IL-17A and IL-17F play central roles in HS, a neutrophilic dermatosis. The presence of IL-1β may partly explain the high expression of IL-17F in lesional HS tissue.

124

News (Medical) associated with Bimekizumab

25 Mar 2025

·endpts.com

Another immunology biotech emerges as Hillstar takes flight with $67M

The flurry of immunology biotech launches continues. Boston-based Hillstar Bio on Tuesday became the latest immunology startup launch, unveiling a $67 million Series A round funded by Droia Ventures, Frazier Life Sciences, Novo Holdings and LifeArc Ventures. The biologics developer has been in the works since 2023, CEO Robert Mabry told Endpoints News . Mabry joined Hillstar in recent months after departing his chief scientific officer post at RNA medicines outfit Orna Therapeutics . “It’s just such a fantastic time for biologics right now. You’re seeing just a renaissance. All the technology is coming to fruition,” Mabry said. With the Series A, Hillstar expects to get into the clinic next year with its first biologic. The startup will begin in axial spondyloarthritis, or axSpA. The inflammatory condition leads to lower back pain, causing arthritis in the spine and other joints and organs. Approved medicines for the condition include Novartis’ Cosentyx, UCB’s Bimzelx and AbbVie’s Rinvoq . Others, like Acelyrin, once had ambitions in the space. Hillstar’s HSB-101 biologic targets TRBV9 + T cells. The goal is to invoke an “immune reset,” Mabry said. Beyond its lead asset, Hillstar could go into cold agglutinin disease, or CAD, according to a job posting for the company. In the rare condition, a patient’s immune system prematurely kills red blood cells. Sanofi sold Enjaymo, its approved drug for the condition, to Recordati for $825 million in October. “It’s still an area that we’re exploring,” Mabry said of CAD. “What we’ve been able to generate is a proprietary dataset using patient samples in that area, so we’re very excited about that as one of many different autoimmune diseases that we can go after.” Leading the biotech’s development is former Boston Pharmaceuticals clinical development SVP Mitchell Keegan. Hillstar’s chief operating officer is Lauren Mifflin, a principal of company creation at one of the startup’s key investors, Frazier Life Sciences. Hillstar’s board includes Mabry, Ingram, Novo Holdings senior partner Kenneth Harrison, Frazier General Partner Dan Estes, Droia Managing Partner Luc Dochez and Droia Partner Matthias Van Woensel. Mabry emphasized that the startup is an asset-focused company with drugs near the clinic — a profile investors have favored over the last few years of a moribund biotech sector. “We’re an asset company, a pipeline company — we’re not a platform technology company,” Mabry said. “That really changes the way you can run a biotech company. It changes the way you use the capital.” Along with the investment funds, another key Hillstar backer is Hummingbird Bioscience, a Singapore-based biotech that originated about a decade ago and that has antibody and antibody-drug conjugate platforms. Earlier this month, Frazier and Novo Holdings backed an ADC spinout from Hummingbird called Callio Therapeutics . “They’ve been a great shareholder for us and so being able to leverage them as part of our development, but also gaining access to other technologies that provide a lot of insight into development, that’s been a great partnership for us,” Mabry said of Hummingbird.

Drug ApprovalImmunotherapy

17 Mar 2025

·www.fiercebiotech.com

Incyte posts phase 3 skin condition wins but details disappoint, sinking stock

While Incyte called the data positive, investors were unconvinced and sent the biotech’s share price down.\n Incyte has delivered a pair of pivotal wins for an oral JAK inhibitor in an inflammatory skin condition. But with the placebo-adjusted response rate down on phase 2, the results drew unfavorable comparisons to rival data and triggered a 15% drop in the biotech’s share price. The JAK1 inhibitor, povorcitinib, could offer an oral alternative to biologics in multiple indications and, if approved, partly offset the loss of exclusivity of Incyte\'s JAKi Jakafi later this decade. Incyte took the candidate into phase 3 trials in the skin condition hidradenitis suppurativa (HS) after seeing (PDF) placebo-adjusted response rates of up to 27.7% in a mid-stage study. Asked by analysts at recent investor events, Incyte executives declined to name the number they were targeting in the phase 3 trials but did say they expected to see a profile that is consistent with the earlier trial. The primary endpoints looked at the number of patients who had a 50% or greater reduction in total abscess and inflammatory nodule count with no increase in abscess or draining tunnel count. In the first study, around 40% of patients on both the low and high dose met the criteria, versus around 30% on placebo. The drug and placebo figures in the second trial were around 42% and 29%, respectively. Adjusted for placebo, the response rates at the low and high dose were 10.5% and 10.9%, respectively, in the first trial. The figure for both doses was 13.7% in the second trial. In the earlier phase 2 trial, Incyte reported placebo-adjusted results of 17.3% and 27.7%, respectively, at the low and high doses used in the pivotal studies. Incyte saw higher placebo-adjusted results in a predefined subgroup of phase 3 patients who previously took a biologic. The biotech also found more people on povorcitinib had a 75% or greater improvement, experienced a reduction in flares and reported a more than three-point improvement on a pain scale. The overall safety profile of povorcitinib was consistent with previous data, according to Incyte.While the biopharma called the data positive, investors were unconvinced and sent the biotech’s share price down around 15% to just $58 in early premarket trading. The drop may reflect unfavorable comparisons between the phase 3 data and both Incyte’s midphase results and the evidence on rival biologics. UCB won approval for Bimzelx in HS after linking the biologic to placebo-adjusted response rates of 19% and 20% after 16 weeks in two phase 3 trials. Novartis’ biologic Cosentyx is also approved in the indication. Povorcitinib has the advantage of oral administration but the data leave scope to question the size of the opportunity that will be open to the small molecule.

Clinical ResultPhase 3Phase 2Drug Approval

17 Mar 2025

·endpts.com

Incyte's stock sinks as pivotal skin disease data disappoint

Incyte’s topline pivotal data for its oral therapy for a painful inflammatory skin condition appear somewhat disappointing, with efficacy falling short of analysts’ expectations and in comparison with marketed drugs like UCB’s Bimzelx. The company’s shares $INCY fell about 10% on Monday morning. Incyte said Monday that the STOP-HS1 and STOP-HS2 studies of povorcitinib met their primary endpoints in patients with moderate-to-severe hidradenitis suppurativa (HS). After three months of treatment, significantly more patients given the JAK1 inhibitor than those given placebo had a reduction of at least 50% in the number of abscesses and inflammatory nodules, with no increase in abscess or draining tunnel count. This measure is known as HiSCR50. But the improvements over placebo were not as extensive as some had hoped. With the lower dose of povorcitinib — 45 mg once daily — the HiSCR50 delta was 10.5 percentage points in STOP-HS1 and 13.7 points in STOP-HS2. The differences versus placebo seen with the higher dose — 75 mg per day — were almost identical. That’s an odd finding, since a higher dose would be expected to work better. “We’ll have to wait for longer-term follow-up to see if there’s a separation of the 45 and 75 [mg doses],” Incyte head of R&D Pablo Cagnoni said during an analyst call to discuss the data. He added that Incyte plans to provide more data on this point later this year. Incyte also said the drug’s efficacy was better in patients who had previously been treated with biologics. Here the deltas over placebo were larger, but the p-value for the difference between the 45 mg dose and placebo in the HS-1 trial was 0.096, missing the generally accepted threshold for significance. William Blair analysts pointed out that the data came in well below the Phase 2 results, which showed placebo-adjusted HiSCR50 response rates of 18 to 28 percentage points. They added that even on an absolute basis, the Phase 3 HiSCR50 response rates for povorcitinib were markedly lesser than those seen in Phase 2. Incyte intends to wait for further data from the trial before seeking approval for the pill, and it’s aiming for an NDA submission at the end of this year or early next year. The Phase 3 data might be good enough for approval, with Incyte saying on the call that it believes regulators will greenlight povorcitinib for both biologic-naïve and -experienced patients. But doctors might have little reason to prescribe the pill when several approved injected drugs still look more effective. For example, in the pivotal HS trials for Bimzelx, the HiSCR50 delta was 19 to 26 percentage points. This was after four weeks of treatment, which is slightly longer than Incyte’s STOP-HS1 and STOP-HS2 trials, but the effect size is much greater. Another competitor is not far behind. There are high expectations for the pivotal data on MoonLake Immunotherapeutics’ antibody sonelokimab in HS. Those data should be revealed in the third quarter of this year.

Clinical ResultPhase 3Phase 2Immunotherapy

100 Deals associated with Bimekizumab

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External Link

KEGG	Wiki	ATC	Drug Bank
D11550	Bimekizumab	-	DB12917

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hidradenitis Suppurativa	European Union	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Iceland	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Liechtenstein	UCB Pharma SA	30 Apr 2024
Hidradenitis Suppurativa	Norway	UCB Pharma SA	30 Apr 2024
Ankylosing Spondylitis	European Union	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Iceland	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Ankylosing Spondylitis	Norway	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	European Union	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Iceland	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Axial Spondyloarthritis	Norway	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	European Union	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Iceland	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Liechtenstein	UCB Pharma SA	15 Jun 2023
Non-radiographic axial spondyloarthritis	Norway	UCB Pharma SA	15 Jun 2023
Erythrodermic psoriasis	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Psoriasis vulgaris	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Pustular psoriasis	Japan	UCB Japan Co. Ltd.	20 Jan 2022
Arthritis, Psoriatic	European Union	UCB Pharma SA	20 Aug 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Enthesitis-Related Arthritis	Phase 3	Canada	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	France	UCB Biopharma SRL	11 Mar 2025
Enthesitis-Related Arthritis	Phase 3	Poland	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Canada	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	France	UCB Biopharma SRL	11 Mar 2025
Juvenile Idiopathic Arthritis	Phase 3	Poland	UCB Biopharma SRL	11 Mar 2025
Chronic large plaque psoriasis	Phase 3	United States	UCB Biopharma SRL	13 Jun 2018
Chronic large plaque psoriasis	Phase 3	Australia	UCB Biopharma SRL	13 Jun 2018
Chronic large plaque psoriasis	Phase 3	Belgium	UCB Biopharma SRL	13 Jun 2018
Chronic large plaque psoriasis	Phase 3	Canada	UCB Biopharma SRL	13 Jun 2018

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04242446 (BE HEARD I, CTgov)	Phase 3	Hidradenitis Suppurativa	505	placebo (Placebo)	rtppvrpfyd = yqpcqcgpwi xeconeqbys (nibxtrcuoa, ddsjeoohbu - iluiskfnin) View more	-	25 Mar 2025
				BKZ (BKZ Dosing Regimen 1)	rtppvrpfyd = yllprlemkw xeconeqbys (nibxtrcuoa, rygyswfbkk - wbgcdaxbrn) View more
BE AGILE (Pubmed \| RMD Open)	Phase 2	Ankylosing Spondylitis \| Axial Spondyloarthritis	-	Bimekizumab 160 mg every 4 weeks	dqyeahvsmo(jvcmhvrglm) = ndtknrywjb goeklojjuo (rowpimgoic ) View more	Positive	01 Jan 2025
NCT03598790 (BE BRIGHT, CTgov)	Phase 3	Plaque psoriasis	1,353	BKZ (Cohort A: BKZ 320 mg Q8W)	fbmoozcytw = ssstyzwfon jyksbsqsmu (xrelfjsmzt, lgadxxkuco - evshvdjntk) View more	-	06 Dec 2024
				BKZ (Cohort A: BKZ 320 mg Q4W)	fbmoozcytw = mizovlwiwy jyksbsqsmu (xrelfjsmzt, nipnqdslve - ekdgtqsgei) View more
NCT04242498 (BE HEARD II, CTgov)	Phase 3	Hidradenitis Suppurativa	509	placebo (Placebo)	mdeetjesrj = nkaagbdgmv jbflxwvxhf (wzhijnxcrk, hkbmsuybay - iztjwwicwg) View more	-	05 Dec 2024
				BKZ (BKZ Dosing Regimen 1)	mdeetjesrj = apzchnwmte jbflxwvxhf (wzhijnxcrk, frxfgaaumw - cblzmibhdg) View more
Pubmed \| Ann Rheum Dis	Not Applicable	Axial Spondyloarthritis	-	Bimekizumab 160 mg	vydlrdxxkp(wmqdnacabr) = rboxfjniuv enjzlmazoz (cjjjtjnryc )	-	01 Dec 2024
				Placebo	vydlrdxxkp(wmqdnacabr) = eaqnmjrjwp enjzlmazoz (cjjjtjnryc )
NCT03412747 \| NCT03370133 \| NCT03536884 \| NCT03410992 \| NCT03598790 (BE VIVID \| BE READY \| BE SURE \| BE BRIGHT \| BE RADIANT, Pubmed \| Dermatol Ther (Heidelb))	Phase 3	Psoriasis	1,107	Bimekizumab	bpnjtllxqn(jgwddlrcmo) = oqmthleuxg xovkdnenyw (fcrutfhnsj ) View more	Positive	01 Dec 2024
NCT03928704 (BE MOBILE 1, CTgov)	Phase 3	Non-radiographic axial spondyloarthritis	274	Placebo (Placebo (up to Week 16) (Global Population))	cffgpksfml = yysjvihxzs suyfvqmmwr (aadikjcmkb, esjjbsetbc - oaohmawpyd) View more	-	13 Nov 2024
				Bimekizumab (Bimekizumab 160 mg Q4W (up to Week 16) (Global Population))	cffgpksfml = fvfoxhityg suyfvqmmwr (aadikjcmkb, eaqwqsixzp - ctkhetgkdg) View more
NCT03355573 (BE AGILE \| OLE \| BE AGILE 2, CTgov)	Phase 2	Ankylosing Spondylitis	255	Bimekizumab	dzkyallaeq = dzapidxthj isdvfsldte (emkfdratah, piwnhmxmgj - wbvleruhwm) View more	-	13 Nov 2024
NCT03895203 (BE OPTIMAL, CTgov)	Phase 3	Arthritis, Psoriatic	852	Placebo+Bimekizumab	frvkdctyfy = gynuviiyld pexguxdpkx (ivjjhjzgyr, ovzsypeftm - tqhuhqizfk) View more	-	23 Oct 2024
NCT03896581 (BE COMPLETE, CTgov)	Phase 3	Arthritis, Psoriatic	400	Placebo	fqoxpjqsqm = mgiddpnaho ysqosfmlbw (fuqbepkuzi, giyoiebcln - cwccjzwfrz) View more	-	16 Oct 2024

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