Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

This study to assess aesthetic improvement following treatment with QM1114-DP.

Start Date23 Jan 2023

Sponsor / Collaborator

Galderma Pharma SA

NCT05463965

/ CompletedPhase 3

A Multicenter, Randomized, Double-Blind, Active-Controlled (BOTOX®) and Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines in Subjects of Chinese Origin

This is a phase 3, multicenter, randomized, double-blind, active-controlled and placebo-controlled study to evaluate the efficacy and safety of 50 units (U) of QM1114-DP for the treatment of moderate to severe GL in male and female subjects of Chinese origin. The study has been designed to test the superiority of QM1114-DP compared to placebo, and the non-inferior efficacy of QM1114-DP compared to onabotulinumtoxinA (BOTOX®), in improving the appearance of moderate to severe GL.

Start Date29 Jul 2022

Sponsor / Collaborator

Galderma Research & Development SNC

CTR20221517

/ CompletedPhase 3

一项评价QM1114-DP治疗中国受试者中度至重度眉间纹的有效性和安全性的多中心、随机、双盲、阳性对照（BOTOX®）和安慰剂对照研究

[Translation] A multicenter, randomized, double-blind, active-controlled (BOTOX®) and placebo-controlled study to evaluate the efficacy and safety of QM1114-DP in the treatment of moderate to severe glabellar lines in Chinese subjects

本研究的主要目的是验证50U QM1114-DP治疗中度至重度GL相对于安慰剂的优效性。如果得到验证，将评价单次给予50U QM1114-DP与20UA型肉毒毒素治疗中度至重度GL的非劣效性。

[Translation]

The primary objective of this study is to verify the superiority of 50U QM1114-DP over placebo in the treatment of moderate to severe GL. If verified, the non-inferiority of a single dose of 50U QM1114-DP to 20UA botulinum toxin in the treatment of moderate to severe GL will be evaluated.

Start Date29 Jul 2022

Sponsor / Collaborator

Q-Med AB

[+2]

100 Clinical Results associated with Botulinum toxin A (Q-Med)

100 Translational Medicine associated with Botulinum toxin A (Q-Med)

100 Patents (Medical) associated with Botulinum toxin A (Q-Med)

Literatures (Medical) associated with Botulinum toxin A (Q-Med)

01 Mar 2025·Dermatologic Surgery

Efficacy and Safety of RelabotulinumtoxinA Liquid Botulinum Toxin in the Treatment of Lateral Canthal Lines: Results From the Phase 3 READY-2 Study

Article

Author: Kontis, Theda C. ; Coquis-Knezek, Sarah ; Palm, Melanie ; Bank, David ; Cox, Sue Ellen ; Ablon, Glynis ; Grunebaum, Lisa ; Ibrahim, Sherrif F. ; Humphrey, Shannon ; Goldman, Mitchel P. ; Rivers, Jason K.

BACKGROUNDRelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A.OBJECTIVEEfficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL).METHODSRandomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported.RESULTSMonth 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo).CONCLUSIONRelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated.

15 Nov 2024·Aesthetic Surgery Journal

Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines

Article

Author: Schwarcz ; Shridharani, Sachin M ; Donofrio, Lisa ; Lin, Xiaoming ; Gold, Michael H ; Moradi, Amir ; Chiang, Melissa ; George, Rosalyn ; Solish, Nowell ; Axén, Eva ; Polder, Kristel ; Biesman, Brian ; Prygova, Inna

AbstractBackgroundRelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced with PEARL (precipitation-free extraction and activity-preserving refined liquid) manufacturing technology, which yields a potent, complex-free formulation.ObjectivesIn the READY-1 study, efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction were examined.MethodsAdults with moderate to severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades improvement from baseline on concurrent investigator (glabellar line investigator live assessment; GL-ILA) and participant (glabellar line subject live assessment; GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for participants scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Participant satisfaction and treatment-emergent adverse events (TEAEs) were reported.ResultsOverall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, n = 199) vs 0% (placebo, n = 67; P < .001). Month 1 investigator-reported none or mild responder rate was 96.3% (RelaBoNT-A) vs 4.5% (placebo; P < .001). GL-ILA scores remained higher with RelaBoNT-A (23.6% [none or mild]; 58.1% [≥1-grade improvement]) vs placebo (1.5%; 10.4%, respectively) through Month 6 (P < .001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end of study). Participants reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A–related TEAEs were low (3.6%) and typically mild.ConclusionsA single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.Level of Evidence: 1

01 Dec 2021·Aktuelle UrologieQ4 · MEDICINE

Interstitielle Zystitis: Interventionelle und operative Therapie – mehr als eine Ultima Ratio

Q4 · MEDICINE

Article

Author: Bschleipfer, Thomas ; Kaftan, Björn

News (Medical) associated with Botulinum toxin A (Q-Med)

31 Jan 2025

·www.businesswire.com

IMCAS 2025: New Galderma Phase IIIb Data Reinforce Rapid Onset and Long-lasting Aesthetic Improvement with RelabotulinumtoxinA (Relfydess™)

ZUG, Switzerland--( BUSINESS WIRE )--Galderma (SWX:GALD), the pure-play dermatology category leader, announced today results from its new phase IIIb RELAX clinical trial demonstrating the rapid onset and the long-lasting duration of aesthetic efficacy, as well as high patient satisfaction and increased confidence, using a single-dose of RelabotulinumtoxinA (Relfydess) to treat frown lines (glabellar lines) 1 . Galderma’s analysis was presented at the International Master Course on Aging Science (IMCAS) 2025 annual congress, held in Paris from January 30 to February 1, 2025. Developed and manufactured by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule 3,4,5 . Previously announced data from the phase III READY clinical trial program demonstrated rapid onset as soon as Day 1 (reported by up to 39% of subjects) and long-lasting efficacy for 6 months (maintained by up to 75% of subjects) when using RelabotulinumtoxinA to treat frown lines and crow’s feet (lateral canthal lines) 2,6 . “We are proud to share our latest RelabotulinumtoxinA data, which reaffirms the sustained clinical effect and patient satisfaction observed in our READY clinical trial program. These findings, together with our proprietary PEARL Technology, reinforce RelabotulinumtoxinA as a safe, effective, and innovative treatment option, and uphold Galderma’s position at the forefront of aesthetic advancements.” BALDO SCASSELLATI SFORZOLINI, M.D., Ph.D. GLOBAL HEAD OF R&D GALDERMA RELAX is a phase IIIb, multicenter, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the long-lasting efficacy and satisfaction of RelabotulinumtoxinA in 132 adults with moderate-to-severe frown lines over a 12-month period 1,7 . Results supported a fast onset of aesthetic improvement at Day 1 (40%; subject-reported) and a duration of effect through 6 months 1 . Subject satisfaction with treatment and appearance was also high, with 92% of subjects satisfied with treatment outcome at Month 1, 69% satisfied at Month 6, and 60% still satisfied at Month 12 1 . Furthermore, at both Month 6 and at Month 12, more than 50% of subjects reported that they had increased self-confidence and looked great for their age, highlighting sustained benefits of RelabotulinumtoxinA over time 1 . Investigators reported high rates of ≥1-grade improvement from baseline, with the highest responder rates at Month 1 (98%), and improvement in GL severity maintained through Month 6 (57%) and Month 9 (28%). RelabotulinumtoxinA continues to be well tolerated with no treatment-related serious adverse events 1 . “I’m excited to see the continued benefits of RelabotulinumtoxinA highlighted in the RELAX study, in my practice. With onset from Day 1 coupled with sustained efficacy and high satisfaction for 6 months, healthcare professionals will be able to address a real need from patients, by offering them the fast acting and long-lasting results they desire, in an easy-to-use liquid formulation, with two treatments a year.” GLYNIS ABLON, M.D., F.A.A.D. ASSOCIATE CLINICAL PROFESSOR UNIVERSITY OF CALIFORNIA, LOS ANGELES Following the successful completion of the European Decentralized Procedure, resulting in a positive decision for the use of Relfydess (RelabotulinumtoxinA), Galderma already received national approvals in 14 European countries, as well as a marketing authorization from Australia’s Therapeutic Goods Administration and the Medicines and Healthcare products Regulatory Agency in the UK. More details on Galderma’s scientific presentations at IMCAS can be found here . About RelabotulinumtoxinA Pioneered by Galderma, RelabotulinumtoxinA is the first and only ready-to-use liquid neuromodulator created with PEARL Technology that is designed to preserve molecule integrity 4,5 . PEARL Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for 6 Months 3,4,5,6 . RelabotulinumtoxinA is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time 4,5 . It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. About Galderma Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com . References: 1 Prather HB, et al. Efficacy and safety of a novel formulation liquid botulinum toxin, RelabotulinumtoxinA, when used for combination treatment of glabellar and lateral canthal lines. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL 2 Ibrahim SF, et al. RelaBoNT-A treatment of glabellar lines and lateral canthal lines across different ethnicity and race: Pooled data from three phase III studies. E-poster presented at: ASDS 2024; October 17-20, 2024; Orlando, FL 3 Sundberg AL and Stahl U. Relabotulinum toxin - a novel, high purity BoNT-A1 in liquid formulation. Presented at: TOXINS 2021; Jan 16-17, 2021; virtual meeting 4 Do M, et al. Purification process of a complex-free highly purified botulinum neurotoxin type A1 (BoNT-A1) - relabotulinumtoxinA. Presented at: TOXINS 2022; July 27-30, 2022; New Orleans, LA 5 Persson C, et al. Patient and Investigator Treatment Experience with Ready-to-Use AbobotulinumtoxinA Solution Versus Powder BotulinumtoxinA for Treatment of Glabellar Lines. Abstract presented at TOXINS 2024; Jan 17-20, 2024, Berlin 6 Based on a literature search conducted in May 2023 across PuBMED, clinicaltrials.gov, and euDRACT 7 Galderma. Data on file. Clinical Study Report for Protocol QM111: RELAX. Galderma Laboratories

Clinical ResultPhase 3Drug Approval

13 Aug 2024

·www.fiercepharma.com

Itching for leadership in 'therapeutic dermatology,' Galderma wins FDA nod for Nemluvio to treat prurigo nodularis

The FDA has approved Galderma Pharma's Nemluvio to treat prurigo nodularis. The nod comes two years after the agency signed off on Regeneron and Sanofi's Dupixent as the first treatment for the skin disorder. Five months after scoring the world’s largest IPO in the first quarter, Swiss skincare specialist Galderma Pharma has earned FDA approval for Nemluvio (nemolizumab) to treat the debilitating and itchy skin disease prurigo nodularis (PN).Nemluvio, which comes in a prefilled pen for monthly subcutaneous injection, is a first-in-class monoclonal antibody that inhibits the signaling of IL-31, a neuroimmune cytokine which fuels the disease mechanisms of PN.Those with the chronic inflammatory skin disorder develop thick, pink-colored nodules on their arms and legs. It is estimated that 181,000 people in the U.S. have the underrecognized and underdiagnosed condition, which causes sleep disturbances. Topical steroids have been the standard of care for PN, bringing with them the potential for severe side effects when used over long stretches of time.Two years ago, Regeneron and Sanofi’s Dupixent became the first treatment approved by the FDA to specifically to treat PN. The monoclonal antibody blocks IL-4 and IL-13 proteins, which cause inflammation and swelling. Dupixent also is available in both a prefilled pen and prefilled syringe for injection under the skin every two weeks.Galderma’s approval is a “first step” in achieving Nemluvio’s “blockbuster platform potential and reinforces our leadership in therapeutic dermatology,” CEO Flemming Ornskov, M.D., said in a release. Galderma picked up nemolizumab in a licensing deal with Roche subsidiary Chugai Pharmaceutical in 2016. It was then a midstage asset under investigation for atopic dermatitis (AD) and pruritis (persistent itch) as it became the first biologic in Galderma’s topical-heavy portfolio.With the deal—which requires Galderma to pay royalties on sales of Nemluvio—the Swiss company gained the rights to develop and commercialize the treatment in all geographies except Japan and Taiwan. In Japan, nemolizumab has been approved for PN and is marketed as Mitchga. It also has been endorsed in Japan to treat AD patients of all ages who also have pruritis.The FDA granted nemolizumab breakthrough therapy designation in 2019 and priority review in February of this year. The agency also is reviewing nemolizumab for the treatment of AD, with a decision expected later this year. Regulators in several jurisdictions—including Europe, Canada and the U.K.—are also reviewing nemolizumab applications in both PN and AD.Approval of Nemluvio was backed by two phase 3 trials, which examined the effects of treatment over 16- and 24-week periods. At week 16 in the studies, 56% and 49% of Nemluvio-treated patients achieved at least a four-point reduction in itch intensity, as measured by a 10-point pruritis rating scale, compared to 16% in both placebo groups.At week 16, 26% and 38% of Nemluvio-treated patients reached a skin-clearance rating of zero or one—on a four-point scale—compared to 7% and 11% in the placebo group. Additionally, 50% and 52% of Nemluvio-treated patients achieved at least a four-point reduction in sleep disturbance at week 16, compared to 12% and 21% in the placebo groups. In March, when Galderma was listed on the SIX Swiss Exchange, it drew an investment of nearly 2.3 billion Swiss francs ($2.6 billion). Galderma said that its public offering was its “next step” in becoming the world’s leading dermatology company.An IPO had been in the works since 2019, when European private equity firm EQT bought the company, formally known as Nestle Skin Health, for $10 billion. Galderma was formed in 1981 as a joint venture between cosmetics maker L’Oréal and food and beverage company Nestlé upon the invention of the first Cetaphil formulation.In October of last year, the FDA rejected Galderma's application for approval of RelabotulinumtoxinA, a liquid formulation of botulinum toxin to reduce wrinkles, citing manufacturing issues.

Drug ApprovalClinical ResultPhase 3Breakthrough TherapyLicense out/in

30 Jul 2024

·pipelinereview.com

Galderma’s Relfydess™ (RelabotulinumtoxinA) Receives Positive Decision for Use in Europe

ZUG, Switzerland I July 30, 2024 I Galderma today announced that it has completed its European decentralized procedure (DCP), resulting in a positive decision for Relfydess TM (RelabotulinumtoxinA – previously referred to as QM1114). Relfydess TM is indicated for the temporary improvement in the appearance of moderate-to-severe glabellar lines (frown lines) at maximum frown and lateral canthal lines (crow’s feet) seen at maximum smile, alone or in combination, in adult patients under 65 years, when the severity of these lines has an important psychological impact on the patient. 9 Following the successful completion of the DCP, national approvals in the 16 concerned countries are now under finalization. Relfydess TM also received a marketing authorization in Australia earlier this year. Relfydess TM is developed and manufactured by Galderma. It is the first and only ready-to-use liquid neuromodulator created with PEARL™ Technology that is designed to preserve molecule integrity to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months for frown lines and crow’s feet. 3,4,7,8 It is optimized for simple volumetric dosing, without reconstitution, to increase ease of use and help ensure consistent dose/volume. 1,10 This positive decision, and the previous Therapeutic Goods Administration approval in Australia, were based on results from the phase III READY (RElabotulinumtoxin Aesthetic Development StudY) clinical trial program, which enrolled more than 1,900 participants. Results showed: 3,4,7,8 Regulatory applications for Relfydess™ for the treatment of frown lines and crow’s feet will continue to be submitted and assessed by additional authorities globally. About Relfydess TM (RelabotulinumtoxinA) Pioneered by Galderma, Relfydess TM is the first and only ready-to-use liquid neuromodulator created with PEARL TM Technology that is designed to preserve molecule integrity. 1,2 PEARL TM Technology is designed to deliver a highly active, innovative, complex-free molecule, with up to 39% of patients seeing effects from day one and up to 75% of patients maintaining improvements for six months. 1-4,7,8 Relfydess TM is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time. 1,10 It was entirely developed and manufactured by Galderma to expand its neuromodulator portfolio as part of the broadest Injectable Aesthetics portfolio on the market. About the READY clinical trial program The READY ( RE labotulinumtoxin A esthetic D evelopment Stud Y ) phase III clinical program is composed of four phase III clinical trials which enrolled more than 1,900 participants. 3-6 The READY trials investigated the safety, efficacy, rapidity of onset and/or durability of Relfydess TM for six months on: About Galderma Galderma (SIX: GALD) is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com . References: SOURCE: Galderma

Phase 3Clinical ResultDrug Approval

100 Deals associated with Botulinum toxin A (Q-Med)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Glabellar frown lines	NDA/BLA	Canada	Galderma SA (Switzerland)	01 Jan 2024
Facial wrinkles	Discovery	China	Q-Med International Trading Shanghai Co. Ltd.	19 Oct 2021
Lateral Canthal Lines	Discovery	Puerto Rico	Galderma Pharma SA	27 Jan 2020
Lateral Canthal Lines	Discovery	United States	Galderma Pharma SA	27 Jan 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


READY (NEWS) Manual	Phase 3	Glabellar frown lines	132	RelabotulinumtoxinA	ckyotesyck(qucpgjiwho) = ekcujqbseb hjldmtiifp (qiwitzljcj ) View more	Positive	31 Jan 2025
NCT05146999 (CTgov)	Phase 3	Glabellar frown lines	132	QM1114-DP (Experimental: QM1114-DP)	gahjirlwow(ffaidhphsy) = chmftldplz xbyewcdvpl (mbavcjyeem, qvcxdzkidy - btuhnbjpwy) View more	-	21 Oct 2024
				placebo (Placebo Comparator: Placebo)	gahjirlwow(ffaidhphsy) = tuwmqmkwte xbyewcdvpl (mbavcjyeem, eecdldfovw - abojailrrf) View more
NCT04247074 (READY-3, CTgov)	Phase 3	-	413	Placebo (Placebo in the LCL and GL)	zjoepmomfh(gjlficnlkl) = qyornzuwbc snrbeeanig (mgypspvvlw, jdjkvojyiz - uceiiuysgm) View more	-	06 Sep 2023
				Placebo+botulinum toxin neuromodulator (Placebo in the LCL + QM1114-DP in the GL)	zjoepmomfh(gjlficnlkl) = vzcttjsssi snrbeeanig (mgypspvvlw, xrhhmorgjx - odgxdnirwx) View more
NCT04225260 (READY-4, CTgov)	Phase 3	Glabellar frown lines \| Lateral Canthal Lines	902	botulinum toxin neuromodulator	ucrjkcqxcu(sznehadnmp) = yjepgmqbtu jnrvdggcbx (lljgyzhwhe, javftgcppd - vnogptqwtv) View more	-	18 Jun 2023
NCT03960957 (CTgov)	Phase 3	Glabellar frown lines	301	AbobotulinumtoxinA (Experimental)	zmogxdhcgc(btrawhbjes) = iahgsmtkah nvrdrzmitv (kwpzufoqtg, fhjpgjvmkx - avbsfopskj) View more	-	11 May 2021
				Placebo (Placebo)	zmogxdhcgc(btrawhbjes) = fpbjhhudqp nvrdrzmitv (kwpzufoqtg, oxiawrcegf - bsdnpxlrwu) View more

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