In this research study the study investigators want to learn more about the effect of two different FDA-approved medication regimens in the treatment of postmenopausal osteoporosis.

Start Date01 Apr 2025

Sponsor / Collaborator

The General Hospital Corp.

NCT06720350

/ Not yet recruitingPhase 4IIT

Efficacy of Romosozumab and Denosumab Combined Treatment in Postmenopausal Osteoporosis Patients with Multiple Fragility Fractures

The aim of this clinical trial is to investigate the effectiveness of romosozumab started without stopping denosumab in patients diagnosed with postmenopausal osteoporosis with a very high risk of fragility fractures and who is under at least 2 years of denosumab treatment. The main questions aimed to answer are:
* Does it effective to prevent fractures add Romosozumab to ongoing denosumab treatment?
* If it is appropiate to quit denosumab for starting 1 year romosozumab treatment?
* If there is complications in denosumab and romosozumab combination treatment?
Researchers will compare the Romosozumab 210mg subcutaneous(sc) monthly plus denosumab 60mg per 6 months sc treatment to prooceeding denosumab treatment and romosozumab 210mg monthly treatment in patient whom denosumab cessaced.
Participians are postmenopousal women with osteoporosis and they are under at least 2 years of treatment with denosumab and they will:
* Add 210 mg monthly romosozumab sc injection or switch to 210 mg monthly romosozumab sc injection or proceed 60mg per 6 months denosumab sc injection
* Visit the clinic at least once every 3 months and first month of new treatment regimen, blood tests per 3 months and Bone mineral density examination per 6 months
* Keep a diary of their symptoms

Start Date15 Jan 2025

Sponsor / Collaborator

Marmara University

NCT06533865

/ Not yet recruitingPhase 3IIT

Romosozumab As an Adjunct to Physiologic Estrogen Replacement in Adolescents and Young Adults with Functional Hypothalamic Amenorrhea

The goal of this study is to determine whether romosozumab will improve bone density in girls and women with functional hypothalamic amenorrhea (cessation of the menstrual period due to intense exercise, stress, or an eating disorder) who have low bone density. Participants will be randomly assigned to receive romosozumab or placebo for 6 months. All participants will receive one IV infusion of zoledronate at the 6 month visit. All participants will also receive transdermal estradiol and cyclic progesterone. We will investigate whether participants who receive active romosozumab will demonstrate greater improvements in bone density at one year than those who receive placebo. We will also compare bone density over a year with healthy controls (girls and women of similar age who have regular menstrual periods).

Start Date01 Jan 2025

Sponsor / Collaborator

The General Hospital Corp.

100 Clinical Results associated with Romosozumab-AQQG

100 Translational Medicine associated with Romosozumab-AQQG

100 Patents (Medical) associated with Romosozumab-AQQG

715

Literatures (Medical) associated with Romosozumab-AQQG

01 Apr 2025·BONE

Impact of prior teriparatide treatment on the effectiveness of romosozumab in patients with postmenopausal osteoporosis: A case-control study

Article

Author: Nagayama, Yoshio ; Hirao, Makoto ; Ebina, Kosuke ; Okada, Seiji ; Okamura, Gensuke ; Fukuda, Yuji ; Tsuboi, Hideki ; Kashii, Masafumi ; Noguchi, Takaaki ; Nakata, Ken ; Kobayakawa, Tomonori ; Miyama, Akira ; Etani, Yuki ; Sugimoto, Atsushi ; Kurihara, Takuya

PURPOSE:

To evaluate the impact of prior teriparatide (TPTD) treatment on the effectiveness of romosozumab (ROMO) in postmenopausal osteoporosis.

METHODS:

In this retrospective, case-controlled, multicenter study, 323 postmenopausal patients were initiated ROMO. Of these, 275 were treatment-naïve, and 48 were switched from TPTD, with uninterrupted ROMO treatment for 12 months. Propensity score matching was applied to ensure clinical comparability, yielding 44 patients in each group. Baseline characteristics included a mean age of 78.0 years, lumbar spine (LS) T-score of -3.6, and total hip (TH) T-score of -2.8. Bone mineral density (BMD) and serum bone turnover markers were evaluated over the 12-month period.

RESULTS:

The increasing rate in the bone formation marker PINP was significantly greater in the treatment-naïve group compared to the TPTD-switched group throughout the 1-12 month period. Conversely, the reduction in the bone resorption marker TRACP-5b was similar between the groups, indicating a diminished anabolic window in the TPTD-switched group. After 12 months, the TPTD-switched group showed lower BMD gains in the LS (10.3 % vs. 17.3 %; P = 0.002) and TH (3.1 % vs. 7.8 %; P = 0.002) compared to the treatment-naïve group. Multiple regression analysis revealed positive associations between the 12-month percentage BMD increases (LS; β = 0.30; 95 % CI = 0.85-11.61; P = 0.024 / TH; β = 0.32; 95 % CI = 0.51-8.56; P = 0.028) and being treatment-naïve compared to prior TPTD treatment.

CONCLUSIONS:

Prior TPTD treatment may attenuate the effectiveness of ROMO, potentially due to diminished bone formation activation.

01 Jan 2025·BONE

Cardiovascular risk assessment for osteoporosis patients considering Romosozumab

Letter

Author: Macrae, F. ; Walsh, K. ; Bailey, S.J. ; Roy, M. ; Hardcastle, S ; Macrae, F ; Cockill, C. ; Walsh, K ; Tobias, J H ; Clark, E.M. ; Bailey, S-J ; Clark, E M ; Cockill, C ; Faber, B G ; Hardcastle, S. ; Faber, B.G. ; Tobias, J.H. ; Roy, M

Cardiovascular risk scoaring tools are suitable for but not interchangable within the osteoporosis clinic.

01 Jan 2025·DRUG SAFETY

Cardiovascular Safety of Romosozumab Compared to Commonly Used Anti-osteoporosis Medications in Postmenopausal Osteoporosis: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials

Review

Author: Chu, Woei-Chyn ; Cheng, Shih-Hao ; Kang, Yi-No ; Chu, William ; Chou, Wen-Hsiang

INTRODUCTION:

The aim of this study was to investigate the cardiovascular safety of romosozumab in postmenopausal women with osteoporosis. Romosozumab, a monoclonal antibody targeting sclerostin, has been shown to increase bone mineral density and reduce the risk of osteoporotic fractures. However, in previous studies, romosozumab therapy was identified as a potential risk factor for cardiovascular events, particularly in patients with predisposing cardiovascular disease.

METHODS:

A systematic literature search was performed in the Cochrane Library, Embase, PubMed, and Web of Science databases to identify randomized controlled trials (RCTs) comparing the safety and efficacy of romosozumab versus alendronate, teriparatide, denosumab, or placebo in postmenopausal women with osteoporosis. Contrast-based network meta-analysis was performed using a random-effects model. The pooled estimates are presented as risk ratios with 95% confidence intervals.

RESULTS:

Of the 5282 articles retrieved, 25 RCTs were included in this review (n = 24,942), and 18 randomized controlled trials (n = 16,777) were included in the network meta-analysis. The results indicated no significant differences in cardiovascular mortality rate between romosozumab and placebo. Regarding the risk of major cardiovascular events, no significant differences were found in the direct evidence or the network meta-analysis with placebo as the reference.

CONCLUSION:

Romosozumab might be a safe option for treating postmenopausal women with osteoporosis. The cardiovascular concerns associated with this treatment seem less significant than previously suggested, although additional real-world data are required to confirm this conclusion.

News (Medical) associated with Romosozumab-AQQG

31 Dec 2024

·www.echemi.com

7 New Drugs Expected to Be Approved in 2025

In 2024, China approved several new drugs, and more blockbuster drugs are expected to be launched in 2025, covering oncology, autoimmune diseases, rare diseases, and other therapeutic areas. Drug Name Mechanism of Action Indications Development Institutions Evantuzumab c-Met/EGFR bispecific antibody Non-small cell lung cancer Johnson & Johnson; Genmab Taqetuzumab CD3/GPRC5D bispecific antibody Multiple myeloma Johnson & Johnson; Genmab Zenidatuzumab Anti-HER2 bispecific antibody Biliary tract cancer Zymeworks; Jazz Pharmaceuticals; BeiGene Inalises PI3Kα inhibitor HR-positive breast cancer Roche; Chugai Pharmaceutical Asunitinib STAMP allosteric inhibitor Speculated use for chronic myeloid leukemia treatment Novartis Tazemetostat EZH2 inhibitor Follicular lymphoma Epizyme; Huadong Medicine; Eisai Relatuzumab-alpha PDL1/TGF-β bispecific antibody Stomach cancer; gastroesophageal junction cancer Hengrui Medicine; Dong-A Pharma Vabysmo EGFR antibody-drug conjugate Nasopharyngeal cancer Lepu Biopharma Tenapanor NHE3 inhibitor Chronic kidney disease hyperphosphatemia Ardelyx; Kyowa Kirin; Fosun Pharma; AstraZeneca Mersutide OXM analog; GLP-1R/GCGR agonist Obesity Eli Lilly; Innovent Biologics Vusirumab IL-1β monoclonal antibody Gouty arthritis Junshi Biosciences Romosozumab SOST monoclonal antibody Osteoporosis Astellas; Amgen; UCB Teplizumab CD3 monoclonal antibody Type 1 diabetes Ligand Pharmaceuticals; Johnson & Johnson; Sanofi Solrepinib Syk inhibitor Immune thrombocytopenic purpura Huadong Medicine BBM-H901 Factor IX gene therapy Hemophilia B Gene Therapy Fitusiran RNAi therapy Hemophilia A; Hemophilia B Sanofi; Alnylam Andexanet alfa Recombinant factor Xa Factor Xa inhibitor antidote Portola Pharmaceuticals Lisocabtagene maraleucel IL-23p19 monoclonal antibody Crohn's disease Boehringer Ingelheim; AbbVie Lemborexant & Daridorexant OX1R antagonist; OX2R antagonist Insomnia Eisai & Idorsia; Sihuan Pharmaceutical; Nxera Pharma Highlights of new drug approvals in 2024 include: 1. Oncology: The world’s first antibody-drug conjugate (ADC) targeting folate receptor alpha (FRα) for ovarian cancer: Mirvetuximab soravtansine. PD-1/VEGF bispecific antibody envafolimab and Nectin-4 ADC enfortumab vedotin. 2. Autoimmune diseases: IL-17A/F monoclonal antibody bimekizumab for ankylosing spondylitis. 3. Rare diseases: Novartis’ complement factor B inhibitor for paroxysmal nocturnal hemoglobinuria (PNH). Blockbuster drugs expected to be approved in 2025 include: Oncology: Amivantamab (Q1) The world’s first c-Met/EGFR bispecific antibody. Highlight: Phase III study showed significant extension of median progression-free survival (mPFS). Talquetamab (Q2) A CD3/GPRC5D bispecific antibody and the world’s first drug targeting GPRC5D. Clinical results: Objective response rate (ORR) in Chinese patients was 69.0%-73.6%. Zanidatamab (Q2) A HER2-targeting bispecific antibody based on Azymetric™ technology. Indication: HER2-positive biliary tract cancer (BTC) with an ORR of up to 52%. Inavolisib (Q3) Roche’s highly selective PI3Kα inhibitor for PIK3CA-mutated breast cancer. Asciminib (Q3) Novartis’ Bcr-Abl allosteric inhibitor for Philadelphia chromosome-positive chronic myeloid leukemia (CML). SHR-1701 (Q4) A PD-L1/TGF-βRII bifunctional fusion protein for first-line treatment of gastric cancer. Phase III study demonstrated significant extension in median overall survival. MRG003 (Q4) China’s first EGFR-targeting ADC with remarkable efficacy in nasopharyngeal carcinoma. Endocrinology and Metabolism: Tenapanor (Q1) The world’s only approved NHE3 inhibitor for controlling hyperphosphatemia in chronic kidney disease patients. Trend Analysis: Continued Innovation in Oncology: The emergence of multiple bispecific antibodies and ADC drugs is making targets and treatment options more precise and diverse. Breakthroughs in Autoimmune and Rare Diseases: New biologics are gradually addressing drug resistance and limited treatment options in previous therapies. Emergence of Domestic Innovative Drugs: Examples include SHR-1701 and MRG003, highlighting the growing research and development capabilities of Chinese pharmaceutical companies. The sequential launch of these drugs will provide new therapeutic options for Chinese patients and enhance China’s position in the global pharmaceutical market.

Drug ApprovalPhase 3Clinical ResultADCImmunotherapy

11 Dec 2024

·endpts.com

Exclusive: Bain-backed musculoskeletal biotech raises $120M for trio of clinical-stage biologics

Angitia Biopharmaceuticals, a California and China biotech developing musculoskeletal biologics, has closed a $120 million Series C led by Bain Capital Life Sciences, the drug developer exclusively told Endpoints News . The 83-employee biotech will put the capital to work on an ongoing Phase 3 trial in China and two global Phase 2 studies. The financing comes about 10 months after Angitia — named after the Goddess of healing — had done another extension to its Series B. The company has now raised a total of $330 million. CEO David Ke founded Angitia in June 2018 after helping lead UCB and Amgen’s romosozumab toward approval. The FDA greenlit the osteoporosis drug in 2019 as Evenity . Prior to his three-year stint at UCB, Ke spent about a decade at Amgen. It was there that he collaborated with Willard Dere, who also worked on four anti-osteoporosis drugs and led Amgen’s global clinical development. Ke is the “best bone biologist in industry,” Dere said in an interview. That’s why he wanted Ke to join him at Amgen. Both would go on to leave Amgen in 2014. Dere returned to academia at the University of Utah and took up board seats at BioMarin, Mersana, Seres and Metagenomi. Ke would go on to a VP role at UCB. Then, after years of tinkering with the idea of starting a company, he launched Angitia. A small, focused biotech would be more efficient and more his speed than big pharma. Ke set up a discovery shop in Guangzhou, China, and a clinical development team in Woodland Hills, CA. Then, two years ago, Dere reunited with Ke as chief medical officer of Angitia. Now, they’re full speed ahead with a fully enrolled Phase 3 in China for AGA111, which is being tested for patients with degenerative disc disease who are undergoing a lumbar interbody fusion. The company has started talks with the FDA about potential studies in the US, but the discussions aren’t finalized and Angitia hasn’t made any concrete decisions yet on the future of the biologic, Ke said. The biotech also has two bispecific antibodies targeting sclerostin and DKK1. The lead one, AGA2118, just entered Phase 2 for post-menopausal women with low bone mass as a potential treatment for osteoporosis, an area with which Ke and Dere are quite familiar. The third clinical-stage asset is dubbed AGA2115. It recently completed a Phase 1 healthy volunteer trial that will have data in the first quarter of 2025 and will move into Phase 2 by the end of next year for osteogenesis imperfecta, Ke said. The Series C financing will get Angitia all the way through the Phase 2 studies and give it flexibility on needing to raise additional capital, Ke said. The biotech will likely seek a pharma partner for a Phase 3 and beyond in osteoporosis , the CEO said. In its discovery labs, Angitia’s scientists are also exploring additional muscle programs and cartilage regeneration targets, Ke said. In the muscle arena, that could include muscle diseases, aging-related muscle loss or therapeutic-induced muscle loss, he added. The latter has been seen with the blockbuster GLP-1 class, and obesity drugmakers are racing to make medicines that preserve muscle, or lean body mass, during the weight-loss process. The financing was led by Bain’s life sciences team, which disclosed a $3 billion fourth fund in September. Angitia is one of multiple biotechs with operations in China that Bain has supported over the years. It’s invested in Beijing oncology biotech Avistone and CNS-focused Tenacia Biotechnology , and it’s helped set up new companies like Kailera and Aiolos to in-license assets from Hengrui and develop the experimental medicines on a broader scale. Joining Bain was new investor Janus Henderson and existing backers like OrbiMed, 3H Health Investment, Legend Capital, Elikon Venture and Yonghua Capital.

Phase 2Drug ApprovalPhase 3Phase 1Executive Change

31 Oct 2024

·www.pharmaceutical-technology.com

Amgen earns higher revenues in Q3 2024, puts rare diseases in the spotlight

After splashing out $27.8bn for Horizon Therapeutics, Amgen is now seeing growth with drugs like Tepezza, Krystexxa, and Uplizna. Credits: Marlon Trottmann/Shutterstock.com Amgen has announced a total revenue of $8.5bn in Q3 2024, a 23% increase from a $6.9bn revenue in the same quarter of last year. The growth is driven by increased product sales by 24%, which included ten products delivering a sales growth in double-digits at minimum, as per a 30 October press release. These products included Repatha (evolocumab), Tezspire (tezepelumab-ekko), Evenity (romosozumab-aqqg), Tavneos (avacopan), and Blincyto (blinatumomab). A 17% growth was seen across Amgen’s innovative oncology portfolio as well as a 21% year over year (YOY) growth and a $1.2bn Q3 revenue was recorded across the rare disease portfolio, said Robert Bradway, chairman and CEO of Amgen in the 30 October conference call. The sales growth was driven by Tavneos, Tepezza (teprotumumab-trbw), Krystexxa (pegloticase) and Uplizna (inebilizumab-cdon), the latter three inflammatory treatments being acquired in October 2023 when Amgen bought Horizon Therapeutics for $27.8bn. The deal with the Horizon was finalised a month after both parties settled an administrative lawsuit with the US Federal Trade Commission (FTC) in September 2023. Following the acquisition of Horizon and the “mechanistic repositioning” of Tepezza, Amgen has launched multiple new projects in rare disease, said CSO Jay Bradner in the conference call. Amgen has since established a rare disease initiative with dedicated leadership in rare disease drug development and will ultimately “more than replenish the rare disease mid- and early-stage pipeline in the years to come”, Bradner added. See Also: Reeves’ 2024 budget promises life sciences investment Bladder cancer diagnoses to top 300,000 in major markets by 2033 Despite reaping success from the trio of rare disease products gained through Horizon, Amgen also whittled its rare disease portfolio by discontinuing the study of its lysophosphatidic acid receptor 1 (LPAR1) antagonist, fipaxalparant, in patients with idiopathic pulmonary fibrosis. The decision was made after a Phase II study of the drug failed to achieve any of its primary or secondary endpoints. The candidate is still being evaluated for the treatment of diffuse cutaneous systemic sclerosis. Amgen also expects to share topline data from the anticipated Phase II study of MariTide (maridebart cafraglutide) in late 2024. The Phase II study is being conducted in adults who are overweight or obese, with or without type 2 diabetes mellitus (T2D). The company is actively planning and on track to initiate a broad Phase III program in obesity, obesity-related conditions and T2D, said Bradner.

Phase 2AcquisitionPhase 3Drug Approval

100 Deals associated with Romosozumab-AQQG

External Link

KEGG	Wiki	ATC	Drug Bank
-	Romosozumab-AQQG	M05BX06	DB11866

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fractures, Bone	CA	Amgen Canada, Inc.	17 Jun 2019
Osteoporosis, Postmenopausal	US	Amgen, Inc.	09 Apr 2019
Osteoporosis	JP	Amgen, Inc.	08 Jan 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Osteogenesis Imperfecta	Phase 3	US	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	JP	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	AU	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	AT	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	BE	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	CA	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	FR	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	DE	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	HU	Amgen, Inc.	22 Apr 2024
Osteogenesis Imperfecta	Phase 3	PL	Amgen, Inc.	22 Apr 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05067335 (CTgov)	Phase 3	Osteoporosis	327	Placebo+Romosozumab (Placebo)	ljfkxpkjdx(kjfbpglgth) = bocercaoyw qazggkwdam (sdlncigaqx, tkoybbypqn - sigozmkhpr) View more	-	05 Dec 2024
				Romosozumab (Romosozumab)	ljfkxpkjdx(kjfbpglgth) = mmkqdsfeig qazggkwdam (sdlncigaqx, uevbalkvfy - puzbqumkhc) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis \| Primary osteoporosis	-	Romosozumab	giokokmoha(vxyjhlggij) = gnavedaxjh aavyhoiokl (gpypeswufu ) View more	-	05 Jun 2024
				Denosumab	giokokmoha(vxyjhlggij) = zvgixvhcxb aavyhoiokl (gpypeswufu ) View more
EULAR2024	Not Applicable	Rheumatoid Arthritis \| Osteoporosis, Postmenopausal	-	Romosozumab	twvoxzxyzs(crhfcowwcf) = vevfoerjsq hkjnmrgdqw (airjcpnycd ) View more	-	05 Jun 2024
				Romosozumab (Rheumatoid Arthritis)	twvoxzxyzs(crhfcowwcf) = rqdhivayxf hkjnmrgdqw (airjcpnycd ) View more
NCT01631214 \| NCT00896532 (Phase 2, ARCH, ENDO2024)	Phase 2/3	low BMD	79	Romosozumab 210 mg QM	zcvpbrponp(nbitabfdep) = vkexjdnyav ycgfehitsn (etsbjbuhqm ) View more	Positive	01 Jun 2024
				Placebo	vknsyuqazk(otseidseyw) = qordgnatsz ogrwffqsom (ftlbqgtmse )
NCT04545554 (CTgov)	Phase 1	Osteogenesis Imperfecta	25	Romosozumab (Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age))	xopwnuyxld(rnodzencqt) = aaznzaiqzs tmuwqiqusw (sgldgbtppi, irzxqaacit - hkwiwbfwey) View more	-	15 Apr 2024
				Romosozumab (Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age))	xopwnuyxld(rnodzencqt) = uhspecctmc tmuwqiqusw (sgldgbtppi, djqqrhnuco - qrhobkyhkh) View more
NCT01575834 \| NCT01631214 (FRAME and ARCH, WCO_IOF_ESCEO2024)	Phase 3	Osteoporosis, Postmenopausal	-	Romosozumab 210mg monthly	ipeokskvka(ogngblhifw) = spveqzixdq gmmcazwqnj (ktmcbsopuv ) View more	Positive	11 Apr 2024
				Denosumab 60mg Q6M	ipeokskvka(ogngblhifw) = yzcwxxuyse gmmcazwqnj (ktmcbsopuv ) View more
Pilot Randomized Controlled Trial (ACR2023)	Not Applicable	-	70	Romosozumab (ROMO)	lemtjsppsd(rihvbkcbsb) = significantly more common in ROMO-treated patients uiylgmhbgd (dhbrwvrrlf ) View more	Positive	14 Nov 2023
				Denosumab (DEN)
EULAR2023	Not Applicable	Glucocorticoid-induced osteoporosis	70	Romosozumab	pkbminaidj(okyhfivwdg) = cragoyiwnf jybduduucb (hbiwkhjszk ) View more	Positive	31 May 2023
				Denosumab	xskhpufbes(xakqfwxdpy) = iahbrsklsy eiemoedooj (kylbmpxjwo ) View more
EULAR2023	Not Applicable	Rheumatoid Arthritis \| Primary osteoporosis	-	Romosozumab	oxgptkjtfr(feiipzxswx) = lvavzyovhb pyodqpbmtb (gofcrrnzjy ) View more	-	31 May 2023
				Denosumab	oxgptkjtfr(feiipzxswx) = qvxhmzcmej pyodqpbmtb (gofcrrnzjy ) View more
EULAR2023	Not Applicable	Osteoporosis	64	ROMO treatment	tvpgpsngkd(kjuahsxema) = ewltnlzgcs wrlnobbrra (talkqrmlvt ) View more	Positive	31 May 2023
				Bisphosphonate treatment	tvpgpsngkd(kjuahsxema) = hpuempfeeg wrlnobbrra (talkqrmlvt ) View more

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