Objective: To improve quality-of-life and health care delivery to patients receiving ureteral stents.
Specific Aims: Evaluate the feasibility, practicality, and qualitative outcomes of utilizing intra-nasal ketorolac in patients with indwelling ureteral stents (Phase I), followed by a randomized trial comparing two non-steroidal anti-inflammatory drugs, intra-nasal Ketorolac versus oral Diclofenac.
Hypotheses: Due to its favorable pharmacokinetics in relieving acute pain, investigators expect improved pain scores and a lower rate of unplanned clinical encounters in patients receiving intra-nasal ketorolac compared to those taking oral diclofenac following ureteroscopic surgery for urolithiasis.
Study Rationale: Following ureteroscopic management of urolithiasis, patient with indwelling ureter stents have higher levels of discomfort compared to those without a ureter stent. Prior studies showed that intramuscular Ketorolac at time of ureter stent removal decreased the incidence of unplanned clinical encounters. Furthermore, onset of analgesic effect by intra-nasal ketorolac is faster than its oral form, and similar its intramuscular and intravenous counterparts.

Start Date01 Nov 2024

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+1]

IRCT20220706055402N6 / RecruitingPhase 3IIT

effect of ketorolac wound infiltration on caesarian post operative pain

Start Date12 Oct 2024

Sponsor / Collaborator-

IRCT20120215009014N531 / RecruitingPhase 3IIT

A comparison of the analgesic effect of ketorolac, morphine and Apotel in head trauma patients: a triple-blind randomized clinical trial

Start Date11 Oct 2024

Sponsor / Collaborator

Hamedan University of Medical Sciences

100 Clinical Results associated with Ketorolac

100 Translational Medicine associated with Ketorolac

100 Patents (Medical) associated with Ketorolac

3,307

Literatures (Medical) associated with Ketorolac

01 Nov 2024·LARYNGOSCOPE

Post‐Tonsillectomy Bleeding and Analgesic Use Before and After the FDA Boxed Warning Against Codeine

Article

Author: Chalamgari, Anjalika ; Carr, Michele M. ; Cottone, Chloe ; Vijay, Arunima

Objective:

The aim of this study was to investigate the trends in post‐tonsillectomy analgesic utility and incidence of post‐tonsillectomy hemorrhage before and after the 2013 FDA Boxed Warning against codeine use after pediatric tonsillectomy.

Methods:

A retrospective study was conducted using TriNetX. A search for patients up to 18 years from 2008 to 2022 within the US Collaborative Network identified 15,648,542 subjects. CPT and ICD‐10 codes were used to identify children who experienced post‐tonsillectomy hemorrhage within 14 days of a tonsillectomy. Analgesics given within 14 days of tonsillectomy were tabulated annually from 2008 to 2022, including codeine, ibuprofen, acetaminophen, oxycodone, ketorolac, and hydrocodone. Bleeding percentage and analgesic utility were grouped into events before and after 2013.

Results:

Mean age at tonsillectomy was 5.6 years (SD = 3.0). Before 2013, the median percentage of children who experienced postoperative bleeding was 1.8% with 0.73% returning to the OR for bleeding control. After 2013, the median percentage of children who experienced postoperative bleeding was 2.4% (p = 0.029), and 0.99% returned to the OR (p = 0.008). Use of post‐tonsillectomy codeine fell from 10.4% to 0.5% (p = 0.003) whereas ibuprofen rose from 2.0% to 63.9% (p = <0.001), acetaminophen from 42.8% to 77.2% (p = <0.001), ketorolac from 1.2% to 9.2% (p = <0.001), and oxycodone from 2.0% to 30.9% (p = <0.001). No change was detected in use of hydrocodone.

Conclusion:

Analgesics used post‐tonsillectomy in children have changed since the FDA Boxed Warning against codeine. There has been a small but statistically significant increase in post‐tonsillectomy bleeding.

Level of Evidence:

4 Laryngoscope, 134:4783–4788, 2024

01 Nov 2024·JOURNAL OF PEDIATRIC ORTHOPAEDICS

Efficacy of a Multimodal Surgical Site Injection for Postoperative Pain Control in Pediatric Patients With Cerebral Palsy Undergoing Hip Reconstruction: A Randomized Controlled Trial

Article

Author: Klomhaus, Alexandra ; Thompson, Rachel M. ; Young, Bailey ; Greig, Danielle ; Sun, Christina A. ; McBride, Daniel ; Swaroop, Vineeta T.

Background::

One in 4 children with cerebral palsy (CP) will undergo orthopaedic surgery during their childhood. Despite its ubiquity, postoperative pain control has been poorly studied in this patient population. Moreover, poor pain management has been associated with adverse surgical outcomes. Multimodal analgesic injections have been well studied in the adult population, demonstrating safety and efficacy in reducing postoperative pain and narcotic consumption, but this modality has not been studied in pediatric patients undergoing similarly complex procedures. The objective of this study was to evaluate the efficacy of a multimodal surgical site injection for postoperative pain control following operative management of hip dysplasia in patients with CP.

Methods::

After obtaining IRB approval, a multicenter, randomized double-blind placebo control trial was completed. Patients below 18 years old with a diagnosis of CP who were scheduled for varus derotation osteotomy (VDRO) of the proximal femur were randomized to receive a surgical-site injection with either a combination of ropivacaine (3 mg/kg), epinephrine (0.5 mg), and ketorolac (0.5 mg/kg) (experimental group) or normal saline (control). All included patients had identical postoperative care, including immobilization, physical therapy, and standardized, multimodal postoperative pain control. Pain scores and narcotic consumption were recorded at regular intervals and compared between groups utilizing two-tailed t test or a nonparametric Mann-Whitney test for quantitative variables and a Fischer exact test for categorical variables.

Results::

Thirty-four patients were included, evenly divided between study arms. There were no significant differences in demographic variables, gross motor function classification system (GMFCS), comorbidities, preoperative radiographic parameters, or concomitant surgeries between groups. Patients in the experimental group required significantly lower narcotic medications at all postoperative time points from PACU until hospital discharge compared with controls (0.41 ± 0.42 vs. 1.87 ± 2.05 total morphine mEQ/kg, P=0.01). Similarly, patients in the experimental group were found to have significantly lower pain scores throughout their hospital stays compared with controls (1.0 ± 0.6 vs. 2.4 ± 1.1 mean pain score, P<0.001). There were no significant differences in operative time, OR time, blood transfusion requirements or hospital length of stay between groups. There were no adverse medication reactions or injection site complications in either group.

Conclusions::

In patients with CP undergoing hip reconstruction, surgical-site injection with a multimodal analgesic combination improves pain control and reduces narcotic consumption in the early postoperative period with no observed adverse effects.

Significance::

Local multimodal analgesic injections should be adopted as part of standard multimodal pain control in this patient population for all osseous surgeries.

Level of Evidence::

Level I—therapeutic.

22 Oct 2024·World Neurosurgery

Safety and Efficacy of Ketorolac After Craniotomy for Tumor Resection.

Article

Author: Koch, Matthew ; Sorrentino, Zachary ; Rahman, Maryam ; Ebrahim, Ghaidaa ; Ghiaseddin, Ashley ; Ali, Madiha ; Chen, Si ; Miller, Patricia ; Reilly, Thomas ; Sriram, Sai ; Chowdhury, Baker

OBJECTIVE:

Postoperative pain is the most common undesirable outcome after neurosurgery. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) which is administered parenterally and carries a theoretical increased risk of bleeding. Our study aims to determine whether ketorolac after craniotomy for tumor resection significantly changes the rate of postoperative adverse events, adequately controls pain, and decreases concurrent narcotic usage.

METHODS:

We performed a retrospective chart review of all adult patients who underwent craniotomy for brain tumor resection from 2013 to 2022. Analysis of patients who received ketorolac and those who did not in the post-operative period were compared for adverse events associated with ketorolac use. Secondary outcomes included patient-reported pain scores and postoperative opioid usage.

RESULTS:

1,114 patients were included, of which 70 received ketorolac in the postoperative period. Patients who received ketorolac often received it after narcotics failed to provide adequate pain control. Patients receiving ketorolac were younger (p=0.001) and had a lower comorbidity index (p=0.041) compared to the non-ketorolac group. Patients receiving ketorolac did not experience a significantly increased rate of bleeding events (p=0.850). Patients recieving ketorolac had significantly higher baseline levels of pain (p=0.018) and opioid usage (p=0.047). When matched for chronic comorbidities including pain disorders, the ketorolac group only displayed higher levels of pain early in the postoperative course (POD 0-1) but not in latter part of the initial postoperative period.

CONCLUSIONS:

Ketorolac is a safe and effective option for pain control after craniotomy for tumor resection. Prospective data is needed to better validate these retrospective observations.

News (Medical) associated with Ketorolac

05 Nov 2024

·www.prnewswire.com

New Study Compares Caldolor® (ibuprofen injection) to ketorolac

– Real World Study Compared Over 150,000 Adult & Pediatric Patients – – Caldolor Associated with Fewer Adverse Drug Reactions – – Caldolor also Improved Healthcare Utilization – NASHVILLE, Tenn., Nov. 5, 2024 /PRNewswire/ -- Specialty pharmaceutical company Cumberland Pharmaceuticals (Nasdaq: CPIX) today announced the publication of new real-world outcomes research demonstrating the safety and healthcare resource advantages of its Caldolor (ibuprofen) injection over ketorolac in both adult and pediatric populations. The study, published in Frontiers of Pain Research, provides compelling evidence that Caldolor is associated with a significantly reduced incidence of adverse drug reactions (ADRs) and improved healthcare utilizations when compared to ketorolac. This extensive, retrospective, payer database analysis evaluated the records of over 17 million patients who had received either ketorolac or Caldolor. Ultimately, 31,046 Caldolor and 124,184 ketorolac adult patients were selected and compared for ADRs and subsequent healthcare resource utilization, which includes inpatient, outpatient and emergency department visits as well as all procedures and prescriptions during the follow up time of 29 days. An additional 5,579 pediatric patients were identified in each arm and compared in a separate claims analysis. Key findings reveal that, in adults, Caldolor was associated with a 45% reduction in renal dysfunction (p<0.001) and a 78% decrease in hematuria rates (p<0.001) when compared to ketorolac. Notably, patients also experienced fewer gastrointestinal complications as well as reduced headaches, nausea and abdominal pain. Among pediatric patients, the results showed Caldolor was associated with a 51-65% lower rate of ADRs, including headache and nausea, with 95% confidence intervals supporting clinical significance. Caldolor also demonstrated a positive impact on healthcare resource utilization (HCRU) when compared to ketorolac, with decreased emergency room and outpatient visits, as well as a shortened hospital length of stay for both adults and children. "These findings underscore Caldolor's potential to improve patient care by reducing their treatment complications, while also delivering potential savings for healthcare systems through decreased hospital readmissions and shortened treatment times," said A.J. Kazimi, CEO of Cumberland Pharmaceuticals. About Caldolor® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Cumberland Pharmaceuticals Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor® (ibuprofen) injection, for the treatment of pain and fever; Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website . Forward-Looking Statements This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's results of operations. These factors include market conditions, competition, an inability of manufacturers to produce Cumberland's products on a timely basis or failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, maintaining an effective sales and marketing infrastructure, natural disasters, public health epidemics, and other events beyond our control, as more fully discussed in the Company's most recent Form 10-K and subsequent 10-Qs as filed with the SEC. There can be no assurance that results anticipated by the Company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. SOURCE Cumberland Pharmaceuticals Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 2

13 Feb 2024

·www.biospace.com

Yinuoke publication demonstrates a new orally delivered molecule that reverses cancer cachexia and increases survival using in vivo models

Yinuoke, a biopharmaceutical company pioneering breakthrough therapeutics for late-stage cancer patients announced today the publication of a manuscript in the peer-reviewed Journal of Cachexia, Sarcopenia and Muscle demonstrating the effectiveness of a new compound in alleviating cachexia and increasing the survival of tumor-bearing mice in a T-cell dependent manner. Cancer cachexia, a devastating tumor-induced immune disorder leading to body wasting and reduced tolerability to therapeutics, occurs in 80% of all cancer patients and causes 25% of deaths. Previous attempts to treat cachexia have failed due to lack of efficacy in stabilizing patient weight and strength. Yinuoke treats cachexia as a tumor-driven autoimmune disorder rather than a metabolic condition. YNK105 reduces systemic inflammation without the toxic side effects caused by NSAIDS that limit its use. The data shows a significant improvement in cachexigenic tumor-bearing mice in overall survival, increases in body, fat, and muscle weight, and reductions in plasma IL-6 and tissue- derived Stat3. Most impressively, cachectic mice achieved a 100% survival rate with a combination treatment of YNK105 and chemotherapy. “This research is the first demonstration that severe cachexia can be halted and reversed”, said Dr. Lingbing Zhang, founder and CEO of Yinuoke. “The ability to reverse cachexia expands the options for late-stage cancer patients to extend survival and live a higher quality of life. Reversing cachexia requires modulating the immune system’s inflammatory response for longer than an NSAID will allow. We identified R-ketorolac as a potential treatment for cachexia and now have significant evidence to support a superior efficacy and safety pro to current approaches using GDF-15 inhibitors or Anamorelin.” “YNK105 has the potential to be a breakthrough treatment for cancer cachexia that I am excited to bring into the clinic,” said Dr. Andrew Hendifar of Cedars-Sinai. “Pancreatic cancer patients are highly susceptible to cachexia and treatment outcomes are severely impacted. Getting control of cachexia is critical for overall survival of patients with pancreatic cancer and especially for stage 4 and late diagnosed patients. These early studies support moving this program into clinical trials.” The research appearing in the February 1st issue of the Journal of Cachexia, Sarcopenia and Muscle is led by Dr. Martina Schweiger and a team of scientists at the Institute of Molecular Biosciences, University of Graz, Austria. About Yinuoke Yinuoke is on a mission to save lives and conquer late-stage cancer through groundbreaking science and the development of first-in-class therapies where no options currently exist. Our vision is to revolutionize late-stage cancer by pushing boundaries and transforming it from a terminal disease to a manageable lifelong condition. Through innovative approaches and tailored treatments, we aim to empower patients with new possibilities for long-term remission and improved quality of life. For inquiries on partnering and investing please contact Suzanne Kennedy at skennedy@yinuokeus.com.

Clinical Result

29 Nov 2023

·www.sciencedaily.com

Certain migraine medications may be more effective than Ibuprofen

For many people with migraine, it can be difficult to find a treatment that is effective and reliable, and information on how medications compare to one another is lacking. A new study draws data from nearly 300,000 people using a smartphone app to help people make decisions about their medications. The study found that certain migraine medications like triptans, ergots and anti-emetics may be two to five times more effective than ibuprofen for treating migraine attacks, according to new research. For many people with migraine, it can be difficult to find a treatment that is effective and reliable, and information on how medications compare to one another is lacking. A new study draws data from nearly 300,000 people using a smartphone app to help people make decisions about their medications. The study found that certain migraine medications like triptans, ergots and anti-emetics may be two to five times more effective than ibuprofen for treating migraine attacks, according to new research published in the November 29, 2023, online issue of Neurology®, the medical journal of the American Academy of Neurology. Migraine attacks are characterized by intense throbbing head pain, sensitivity to light and sound, nausea or vomiting. Previous research has shown migraine can also be associated with cognitive issues. All of these symptoms may impact a person's quality of life and productivity. "There are many treatment options available to those with migraine. However, there is a lack of head-to-head comparisons of the effectiveness of these treatment options," said study author Chia-Chun Chiang, MD, of the Mayo Clinic in Rochester, Minnesota, and member of the American Academy of Neurology. "These results confirm that triptans should be considered earlier for treating migraine, rather than reserving their use for severe attacks." For the study, researchers included over 3 million migraine attacks from nearly 300,000 users that were self-reported by people using a smartphone app during a six-year period. The app allows users to monitor the frequency of migraine attacks, triggers, symptoms and medication effectiveness. For those migraine attacks, participants entered 4.7 million treatment attempts with various medications into the app. They recorded in the app whether a medication was helpful or not. Researchers then used that information to calculate the effectiveness of each drug compared to ibuprofen. Researchers looked at a total of 25 medications among seven drug classes. Different dosages of medication and formulas of each medication were combined in this analysis. The study found that the top three classes of medications more effective than ibuprofen were triptans, ergots and anti-emetics. Triptans were five times more effective than ibuprofen, ergots were three times more effective and anti-emetics were two and a half times more effective. When looking at individual medications, the top three were eletriptan which was six times more effective than ibuprofen, zolmitriptan which was five and a half times more effective and sumatriptan which was five times more effective. Researchers found that when using eletriptan, participants found it helpful 78% of the time. Zolmitriptan was helpful 74% of the time and sumatriptan was helpful 72% of the time. Ibuprofen was helpful 42% of the time. Researchers also looked at other groups of medication such as acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs other than ibuprofen were 94% more effective than ibuprofen. Participants found ketorolac helpful 62% of the time, indomethacin was helpful 57% of the time, and diclofenac was helpful 56% of the time. However, acetaminophen was helpful 37% of the time and found to be 17% less effective than ibuprofen when used for treating migraines. Additionally, a common combination of medications used to treat migraine, aspirin, acetaminophen and caffeine was also evaluated and found to be 69% more effective than ibuprofen. "For people whose acute migraine medication is not working for them, our hope is that this study shows that there are many alternatives that work for migraine, and we encourage people to talk with their doctors about how to treat this painful and debilitating condition," said Chiang. A limitation of the study was evaluations of medications could be influenced by a user's expectations of the medication or the dosage they took. Another limitation was that newer migraine medications, gepants and ditans, were not included in the study due to the low amount of data when the study was conducted and lack of availability in many countries. The study was supported by the Kanagawa University of Human Services.

Clinical Result

100 Deals associated with Ketorolac

External Link

KEGG	Wiki	ATC	Drug Bank
D08104	Ketorolac	M01AB15	DB00465

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	Phase 3	-	Neumentum, Inc.Startup	-
Post procedural inflammation	Phase 1	US	Layerbio, Inc.	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRNewswire Manual	Not Applicable	Pain	-	Caldolor (ibuprofen) injection	wcgdycjncs(bjflshxehx) = snctdmjyaa dcycdjsdhx (nqdhozbegq ) View more	Positive	05 Nov 2024
				ketorolac	-
CNS2023	Phase 1/2	Migraine Disorders	17	Normal Saline, Prochlorperazine, Ketorolac	gwgdzcnhnf(csiixkatdc) = ijuxholejk pvqluwllap (atojyrhamg ) View more	Positive	01 Oct 2023
SALT (ARVO2023)	Not Applicable	-	94	Post-SLT ketorolac	ikxewdchra(molcfomdzh) = glnizspsmv bzhjwhqrtb (plupswvirx ) View more	Negative	01 Jun 2023
				No topical anti-inflammatory agent	ikxewdchra(molcfomdzh) = sfjhdzidjo bzhjwhqrtb (plupswvirx ) View more
TCTR20200909006 (Pubmed) Manual	Phase 3	De Quervain Disease	60	Lidocaine+Adrenaline+Ketorolac	xmxrlvoxav(oxtdzwfpiu) = punakqgibv qnwfienalp (nyhunkahof, 2.0)	Negative	01 Sep 2022
				Lidocaine+Adrenaline+Triamcinolone Acetonide	xmxrlvoxav(oxtdzwfpiu) = ukfsksfjua qnwfienalp (nyhunkahof, 3.2)
NCT02358681 (CTgov)	Phase 3	Migraine Disorders	59	Placebo, intravenous+Ketorolac, intranasal (Ketorolac, Intranasal)	irudmorpro(swjjpseczc) = ylwxapnetz wkcitkfscr (hokuahotdf, nayfkmenrr - imyolebcgi) View more	-	12 Jan 2022
				Placebo, intranasal+Ketorolac, intravenous (Ketorolac, Intravenous)	irudmorpro(swjjpseczc) = febrdtnsdc wkcitkfscr (hokuahotdf, fllgiqzdwm - ghjaaefjuk) View more
PD26-02 (AUA2021)	Not Applicable	-	-	Ketorolac	czzttxhbid(slceplyrna) = jpldvgpefx ibeftvkkcy (uyxjwmwdha ) View more	Positive	01 Sep 2021
				TORADOL (KETOROLAC) (Control)	czzttxhbid(slceplyrna) = hknzvnffkt ibeftvkkcy (uyxjwmwdha ) View more
NCT01806259 (KBCt \| KBC, CTgov)	Phase 3	Breast Cancer \| Inflammation	203	Ketorolac 30 mg IV (Ketorolac 30 mg)	vvotstpadl(xmzvoidxpk) = imtblzmqmq kydpsujoch (iaftntveuo, qbfgbjdcyf - tmtxqypoqv) View more	-	18 Jan 2020
				Placebos (NaCl 0.9% 3mL)	vvotstpadl(xmzvoidxpk) = ckeazcddhy kydpsujoch (iaftntveuo, edmgiqyblq - nlrcslxbxg) View more
AAO2019	Not Applicable	Ophthalmologic surgical procedures	-	Intravenous Ketorolac (IVK)	lapgpjxmct(dxovlfsosc) = jvifocrjnf wfauywfysm (ucbbnnmsqc )	Positive	12 Oct 2019
				Ketorolac	lapgpjxmct(dxovlfsosc) = puuemqprcu wfauywfysm (ucbbnnmsqc )
Pubmed	Not Applicable	-	18	S (-) ketorolac	vgqlrnywak(gdojklokdm) = gsatyybwdl hnlyctibzv (tdtomchdmu ) View more	-	01 Sep 2019
				R (+) ketorolac	vgqlrnywak(gdojklokdm) = oigotemftl hnlyctibzv (tdtomchdmu ) View more

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