A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS

The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is.
The study is seeking for participants who are:
* Male or female who are 18 years of age or older.
* Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen.
PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.

Start Date27 Mar 2023

Sponsor / Collaborator

Pfizer Inc.

NCT05745701 / CompletedPhase 1

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE AND CYCLOSPORINE ON THE SINGLE-DOSE PHARMACOKINETICS OF PF-07081532 IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS

This is a Phase 1, open-label, fixed-sequence, 3-period study to evaluate the effect of multiple doses of itraconazole and a single dose of cyclosporine on the single-dose PK of PF-07081532 in otherwise healthy, overweight or obese, adult female and male participants.
The 3 study periods will be conducted consecutively without a break.

Start Date22 Feb 2023

Sponsor / Collaborator

Pfizer Inc.

NCT05671653 / TerminatedPhase 1

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY-STATE DOSE LEVELS OF PF-07081532 ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, OMEPRAZOLE AND AN ORAL CONTRACEPTIVE, AND THE EFFECT OF STEADY-STATE SEMAGLUTIDE ON THE PHARMACOKINETICS OF SINGLE-DOSE MIDAZOLAM, IN OBESE ADULT FEMALE PARTICIPANTS

Two different groups of healthy volunteers will be chronically treated with GLP-1 drugs PF-07081532 or alternatively Semaglutide. The effect of these GLP-1 drugs on a single dose of the common sedative medication midazolam blood levels will be measured. The effect of chronic PF-07081532 on single doses of the common stomach acid medication omeprazole, and common birth control medication blood levels will also be measured. The hypothesis is that chronic administration of the GLP-1 drugs will minimally affect blood levels from these common medications.

Start Date19 Jan 2023

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Lotiglipron

100 Translational Medicine associated with Lotiglipron

100 Patents (Medical) associated with Lotiglipron

Literatures (Medical) associated with Lotiglipron

01 Jan 2025·DIABETES OBESITY & METABOLISM

Evaluation of an oral small‐molecule glucagon‐like peptide‐1 receptor agonist, lotiglipron, for type 2 diabetes and obesity: A dose‐ranging, phase 2, randomized, placebo‐controlled study

Article

Author: Buckley, Gina ; Vasas, Szilard ; Haggag, Amina Z. ; Frederich, Robert ; Amin, Neeta B. ; Palmer, Alexandra ; Zhu, Qi ; Tsamandouras, Nikolaos ; DuBrava, Sarah J. ; Johnson, Margot ; Schuster, Tilman ; Zmuda, Witold ; Smith, Timothy R.

Abstract:

Aim:

The aim was to investigate the effects of lotiglipron, a once‐daily, oral small‐molecule glucagon‐like peptide‐1 (GLP‐1) receptor agonist, in participants with type 2 diabetes (T2D) or obesity.

Materials and Methods:

A phase 2, randomized, double‐blind, placebo‐controlled, dose‐ranging study investigated the efficacy and safety of lotiglipron. The study was terminated early for safety reasons after routine data and monitoring review. The planned analyses for the end points were modified prior to unblinding the study.

Results:

In total, 901 participants were treated with at least one dose of the study drug (T2D cohort: n = 512, obesity cohort: n = 389). Although the majority of participants who were randomly assigned to higher doses did not reach their target maintenance dose, statistically significant changes in HbA1c and body weight were observed. In the T2D cohort, reductions in HbA1c were observed across all lotiglipron doses at week 16 (p < 0.0001), with least squares mean decreases up to −1.44% (90% confidence interval [CI]: −1.63, −1.26) (lotiglipron 80 mg), versus placebo, −0.07% (90% CI: −0.25, 0.11). In the obesity cohort, decreases in body weight were observed across all lotiglipron doses at week 20 (p < 0.01), up to −7.47% (90% CI: −8.50, −6.43) (lotiglipron 200 mg, five‐step titration), versus placebo, −1.84% (90% CI: −2.85, −0.83). Across cohorts, the most frequently reported treatment‐emergent adverse events were gastrointestinal related (most mild to moderate severity), with nausea being the most common (ranging from 4% [placebo] to 28.8% [80 mg] in the T2D cohort and 12.5% [placebo] to 60.6% [200 mg, four‐step titration] in the obesity cohort). Transaminase elevations were observed in a subset of participants (6.6% and 6.0% of participants on lotiglipron in the T2D and obesity cohorts, respectively, compared with 1.6% on placebo in the obesity cohort).

Conclusions:

The efficacy (HbA1c and/or body weight) of a range of lotiglipron doses was demonstrated in T2D and obesity cohorts. The safety profile was largely consistent with what has been previously known about the mechanism of action. Our results are unique in reporting elevations in liver transaminases in a subset of participants treated with lotiglipron, with attempts to identify the at‐risk population unsuccessful and therefore clinical development of lotiglipron terminated.

ClinicalTrials.gov:

NCT05579977.

01 Aug 2024·DIABETES OBESITY & METABOLISM

Once‐daily oral small‐molecule glucagon‐like peptide‐1 receptor agonist lotiglipron (PF‐07081532) for type 2 diabetes and obesity: Two randomized, placebo‐controlled, multiple‐ascending‐dose Phase 1 studies

Article

Author: Tsamandouras, Nikolaos ; Brown, Lisa S. ; Saxena, Aditi R. ; Carvajal‐Gonzalez, Santos ; Buckeridge, Clare ; Hernandez‐Illas, Martha

Abstract:

Aim:

To investigate the effects of lotiglipron (PF‐07081532), a once‐daily, oral small‐molecule glucagon‐like peptide‐1 receptor agonist, in participants with type 2 diabetes (T2D) and/or obesity.

Materials and Methods:

Two Phase 1 randomized, double‐blind, placebo‐controlled, multiple‐ascending‐dose studies were conducted to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of lotiglipron.

Results:

Across the studies, 74 participants with T2D were treated for 28 or 42 days, and 26 participants with obesity without diabetes were treated for 42 days, following randomization to placebo or lotiglipron (target doses 10–180 mg/day, with dose titration to higher target doses). Most adverse events were mild (89.6%), with nausea the most frequently reported in both studies. There were no clinically meaningful adverse trends noted in safety laboratory tests, vital signs, or electrocardiogram parameters. In participants with T2D, lotiglipron resulted in dose‐dependent reductions in mean daily glucose. The 180‐mg dose was associated with least squares mean decreases from baseline in glycated haemoglobin (−1.61% [90% confidence interval {CI} –2.08, −1.14] vs. −0.61% [−1.56, 0.34] for placebo) and body weight (−5.10 kg [90% CI –6.62, −3.58] vs. −2.06 kg [90% CI –4.47, 0.36] for placebo) after 42 days; a similar magnitude of weight loss was seen in participants with obesity. The observed pharmacokinetic profile supported once‐daily dosing.

Conclusions:

The profile of once‐daily lotiglipron with doses up to 180 mg, as observed in these two Phase 1 studies, indicated a safety and tolerability profile consistent with the mechanism of action, with dose‐dependent reductions in glycaemic indices (T2D) and body weight (both populations) after multiple doses. Clinicaltrials.gov identifier: NCT04305587, NCT05158244.

News (Medical) associated with Lotiglipron

07 Oct 2024

·www.pharmaceutical-technology.com

Activist investor Starboard forges $1bn stake in Pfizer to swing profits

Shares in the company are trading nearly 54% down compared to pandemic-high prices. Image credit: Shutterstock/ ShU studio. Activist investor Starboard Value has built a $1bn stake in Pfizer to seek a turnaround in the drugmaker’s tumbling share price, according to sources familiar with the matter. US hedge fund Starboard has approached former Pfizer CEO Ian Read and recent CFO Frank D’Amelio to help forge a post-pandemic route to profit, as per Wall Street Journal, which originally reported the news. Despite the success of its Covid-19 mRNA vaccine which drove Pfizer’s 2022 revenue to record profits, Pfizer shares have steadily fallen as demand for Covid-19-related products weans . Shares in the company are trading nearly 54% down at the most recent market close compared to its all-time high closing price in December 2021, during the Covid-19 pandemic. Pfizer has a market cap of $162bn. While details of Starboard’s roadmap at Pfizer are unknown, the $1bn stake means the activist investor now holds 0.6% of Pfizer’s value. When reached for comment by Pharmaceutical Technology , a Pfizer spokesperson did not confirm the investment and stated the company does not comment on market speculation or rumours. Activist investors are typically specialist hedge funds that buy a large stake in a publicly traded company to influence how it’s run, with a view to increase the target company’s share price and improve its performance. See Also: Almac Group North American Headquarters Expansion, Pennsylvania, USA LOTTE BIOLOGICS’ East Syracuse Pharmaceutical Manufacturing Facility, US While Pfizer tackles weaker revenue for Covid-19 vaccines and drugs, along with an underwhelming launch of its respiratory syncytial virus (RSV) vaccine Abrysvo, Moderna and GSK have also struggled with their respective RSV vaccine revenues. Pfizer’s attempts to join the lucrative weight loss market have also hit difficulties. The company reworked a twice-daily version of its candidate danuglipron into a once-a-day pill following high rates of side effects in a mid-stage trial. The company had already dropped another daily weight-loss drug, called lotiglipron, due to safety concerns as it raised levels of liver enzymes in some patients. The company also terminated its late-stage Duchenne muscular dystrophy (DMD) drug after a lack of benefit in a Phase III trial and a patient death in Phase II study. Pfizer’s CEO Albert Bourla, who was key in securing the Covid-19 vaccine partnership with BioNTech , admitted in an investor call in January that Pfizer had endured a difficult 2023. Pfizer’s revenue was still ultimately down 41% in 2023, with Bourla taking a 35% reduction in pay during the year. The CEO missed out on a bonus as Pfizer’s 2023 financial performance was “below pre-established targets,” as per the company’s annual report . Bourla stated that the company entered 2024 with a “solid foundation” and that its commitment to the “next wave of pipeline innovation will fuel Pfizer’s growth”. Following Q1 net income declines of 44%, Pfizer announced a cost reduction programme in May this year, expected to save around $1.5bn by 2027. Despite a turbulent financial performance, Pfizer has been active in the M&A market over the past year, with several high-profile deals wrapped up to solidify product lines. The biggest by far was the company’s $43bn takeover of cancer drugmaker Seagen to stake a claim in the burgeoning antibody-drug conjugate market. Pfizer’s acquisition of biotech Global Blood Therapeutics (GBT) was in the spotlight recently, after lead sickle cell disease drug Oxbryta (voxelotor), which was bought as part of the deal, had to be pulled off the market with clinical studies also discontinued due to adverse side effects.

VaccineAcquisitionPhase 2mRNAIPO

11 Jul 2024

·www.fiercebiotech.com

Pfizer bounces back in obesity, moving once-daily oral drug toward pivotal trials after earlier missteps

Shares in Pfizer rose almost 3% to above $29 in premarket trading. Pfizer has dragged the oral GLP-1 candidate danuglipron back from the brink. Months after dropping one version of the asset, the Big Pharma has vowed to advance a once-daily, modified-release formulation on the strength of “encouraging pharmacokinetic data.” The drugmaker axed twice-daily danuglipron in December 2023 after reporting discontinuation rates in excess of 50% across all the studied doses. The data dealt another blow to Pfizer’s obesity program, which was still reeling from the discontinuation of once-daily lotiglipron in response to signs of liver dysfunction. When Pfizer dropped twice-daily danuglipron, a pharmacokinetic study of the once-daily version of the molecule kept rolling. Having a once-daily formulation would make Pfizer more competitive against rivals such as AstraZeneca, Eli Lilly, Structure Therapeutics and Viking Therapeutics. Thursday, Pfizer shared a high-level overview of what was learned in the once-daily trial. The researchers saw “encouraging pharmacokinetic data for several candidates with one showing the most favorable profile,” Pfizer said, and “a safety profile consistent with prior danuglipron studies.” No patients had elevated liver enzymes. Talking to investors in October 2023, Mikael Dolsten, M.D., Ph.D., chief scientific officer at Pfizer, said “it's within our reach, if we decide to start the pivotal study next year, to do it with a once-a-day molecule.” However, the data from the pharmacokinetic study have left Pfizer with work to do before starting pivotal clinical trials. First, the company plans to conduct dose-optimization studies “with a focus on the preferred formulation to inform the registration enabling studies.” Pfizer will assess multiple doses in the optimization studies over the second half of 2024. Every month may matter in what is shaping up to be a highly competitive space. Talking at an investor event in June, Pfizer CEO Albert Bourla, Ph.D., said (PDF) danuglipron was two years behind Lilly’s oral candidate and two years ahead of AstraZeneca’s program. Bourla’s analysis of the race excluded biotechs, but the CEO said “we are looking [at] all of them” when asked whether he was paying attention to smaller players. Pfizer has two other oral weight loss candidates with undisclosed mechanisms of action, but danuglipron is its lead attempt to get an oral GLP-1 drug to market. If once-daily danuglipron had failed, Pfizer could have looked to M&A to regain a spot in the oral GLP-1 race. Shares in Pfizer rose almost 3% to above $29 in premarket trading. Shares in Viking fell more than 4% to $55.50.

14 Jun 2024

·www.pharmaceutical-technology.com

Pre-diabetes rates increase amidst a renaissance for type 2 diabetes research

There are currently six GLP-1RAs available in the UK. Image credit: Shutterstock / KK Stock. England’s National Health Service (NHS) has reported an 18% increase in the number of people with non-diabetic hyperglycaemia – also known as pre-diabetes. The latest National Diabetes Audit shows that 3,615,330 people registered with a GP have pre-diabetes and are at a greater risk of developing type 2 diabetes (T2D). Compared to 2023 figures, this is up by more than half a million patients. The NHS has rolled out a range of programmes and services to curb the proportion of this cohort that are diagnosed with T2D. However, for those who still develop diabetes, a much-changed treatment landscape now exists. Previously, metformin and other anti-hyperglycaemic medications were the only pharmaceutical options for patients with T2D. Metformin is still the first-line treatment of choice for T2D patients due to its efficacy, safety, and cost. Now, the proliferation of glucagon-like peptide-1 receptor agonists (GLP-1RAs), in particular, has transformed diabetes care. These drugs work by mimicking the GLP-1 hormone that is normally released after eating, which stimulates various glycaemic control mechanisms. See Also: FDA grants approval for Alexion’s NMOSD treatment AbbVie signs agreement to acquire Landos Biopharma for $212.5m GLP-1RA options on the NHS There are currently six GLP-1RAs available in the UK. The more popular options are Eli Lilly’s Mounjaro (tirzepatide) and Novo Nordisk ’s Ozempic (semaglutide). Novo Nordisk also markets semaglutide in the oral form as Rybelsus. Other approved treatments include Eli Lilly’s Trulicity (dulaglutide), Novo Nordisk’s Victoza (liraglutide), and Sanofi ’s Lyxumia (lixisenatide), all GLP-1RAs. The sharp rise in uptake of GLP-1RAs has outpaced supply, however, leading to shortages in the NHS earlier this year. Off-label prescribing worsened the shortages, prompting guidance from a Medicines Safety Notice in March telling clinicians to only prescribe the drugs for their licensed indication. At the same time, an increased supply of Rybelsus, and the introduction of Mounjaro in the supply chain have been highlighted by charity Diabetes UK. The shortages are likely expected to last until the end of this year, according to Douglas Twenefour, head of care at Diabetes UK. Twenefour added: “We fully support the instruction that GLP-1 medications should not be prescribed off-label under any circumstances while there is an ongoing shortage impacting people with T2D.” Global pharma scene Novo Nordisk and Eli Lilly, market leaders for GLP-1RAs, are now the two biggest pharmaceutical companies in the world. Novo Nordisk has a market cap of $436bn while Eli Lilly’s market cap is $839.5bn. Their success has meant other players in the industry have been making a push into diabetes – and more broadly weight loss – treatments. AstraZeneca received US Food and Drug Administration (FDA) approval earlier this week for its paediatric type 2 diabetes treatment Farxiga (dapagliflozin). Farxiga, marketed as Forxiga in the EU, is already approved as an adjunct to diet and exercise to improve glycaemic control in adults with T2D. The company signed a deal worth a potential $1.85bn last November to gain an exclusive licence to Eccogene’s T2D pill ECC5004, at the time in the early stages of development. Roche signalled its intent to join the GLP-1RA arena a month later with its acquisition of Carmot Therapeutics for $2.7bn, along with $400m in milestone payments. Pfizer is eying the lucrative metabolic disease market but suffered a setback after its weight loss pill, lotiglipron, caused serious side effects in a Phase IIb trial, causing the company to drop its GLP-1RA candidate . Pfizer will rest its hopes on its other candidate, danuglipron, to take on competitors.

Drug ApprovalAcquisitionPhase 2License out/in

100 Deals associated with Lotiglipron

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 2	US	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	JP	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	BG	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	CA	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	CZ	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	HU	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	PL	Pfizer Inc.	27 Oct 2022
Diabetes Mellitus, Type 2	Phase 2	PR	Pfizer Inc.	27 Oct 2022
Obesity	Phase 2	US	Pfizer Inc.	27 Oct 2022
Obesity	Phase 2	JP	Pfizer Inc.	27 Oct 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05788328 (CTgov)	Phase 1	Obesity	16	DE (Period 1: DE 150 mg)	zjbsepwypx(qshkcthmqe) = vzzgjkhpsz bzglkldyco (jnkmmbrhcj, jmottustvn - hgaaeelymy) View more	-	15 Nov 2024
				DE+PF-07081532 (Period 4: DE 150 mg + PF-07081532 80 mg QD)	zjbsepwypx(qshkcthmqe) = fnovwkzqyk bzglkldyco (jnkmmbrhcj, hrsqzyxvkr - drevslinkm) View more
NCT05510245 (CTgov)	Phase 1	Diabetes Mellitus, Type 2 \| Functional disorder	18	PF-07081532 (Mild Renal Impairment)	lbyabtqtsl(jgyejzklxr) = tkjjwlweet kzonwzthmr (dssztqnjxv, vmjrtzvlam - mrehwdnvbw) View more	-	05 Nov 2024
				PF-07081532 (Moderate Renal Impairment)	lbyabtqtsl(jgyejzklxr) = gguhaobnzp kzonwzthmr (dssztqnjxv, nrrxjakbnf - kkiolhuxhe) View more
NCT05652647 (CTgov)	Phase 1	-	6	[14C]PF-07081532 (Period 1: [14C]PF-07081532 30 mg Oral)	bpgjdnwblc(mluexnyupa) = pcprwcbhdr ctgunxwmtz (tkqbhjqhvv, tkcbxiqpiz - hmrtcmshcw) View more	-	24 Sep 2024
				[14C]PF-07081532+PF-07081532 (Period 2: PF-07081532 30 mg Oral + [14C]PF-07081532 100 µg IV)	ocinvajzjp(hsufshrcib) = mzdcgblurc bmnvuecxnm (jsblvrqlov, lhpoxacgir - vznuebgedy) View more
NCT05745701 (CTgov)	Phase 1	Obesity	16	Lotiglipron (Active Comparator: Period 1: Lotiglipron)	xmvicahywu(ajyerfglby) = mnxnmxilhx qjjkrhtkey (mxklfnojgm, ubbnieemni - fqorzubbkd) View more	-	23 Sep 2024
				Cyclosporine+Lotiglipron (Experimental: Period 2: Lotiglipron + Cyclosporine)	xmvicahywu(ajyerfglby) = ovrmidtnrv qjjkrhtkey (mxklfnojgm, yvbrvzldye - dbgfqtqlwl) View more
NCT05478603 (CTgov)	Phase 1	Liver Injury	24	PF-07081532 (Without Hepatic Impairment)	aednygsfhy(downwqfdfg) = xhgnovhciv xzuvnqubne (aqgfoslccy, lehbbybgbs - wzgcvzxofw) View more	-	22 Aug 2024
				PF-07081532 (Mild Hepatic Impairment)	aednygsfhy(downwqfdfg) = hsrnbosjdy xzuvnqubne (aqgfoslccy, pqclypaolp - upetcnyrqn) View more
NCT05158244 (CTgov)	Phase 1	Diabetes Mellitus, Type 2	34	Placebo (Placebo (Type 2 Diabetes Mellitus [T2DM]))	wdjerxiawo(rrabavnglj) = xbxhsfjftr ivggsbimyk (habizofadm, nbxbxbapay - hwfjivwvoa) View more	-	12 Aug 2024
				PF-07081532 (PF-07081532 20-60 mg (T2DM))	wdjerxiawo(rrabavnglj) = dgqvgtnpqs ivggsbimyk (habizofadm, yljeggbwdu - oeqhkvbcfc) View more
NCT05158244 \| NCT04305587 (Pubmed) Manual	Phase 1	Diabetes Mellitus, Type 2 \| Obesity	74	Lotiglipron 10mg/day	elcvchvaci(paailwhhfu) = Most adverse events were mild (89.6%), with nausea the most frequently reported in both studies. zryxozgtnt (siskzkhldy )	Positive	01 Aug 2024
				lotiglipron 180-mg (T2D)
NCT04305587 (Phase 1, CTgov)	Phase 1	Diabetes Mellitus, Type 2	66	Placebo (Placebo Part A)	sieezktjxt(jzdphvtrmu) = qsqhgjyers dtyeyvtyjp (mgupyparqm, qdgvrssosc - ymweillnym) View more	-	05 Feb 2024
				PF-07081532 (PF-07081532 10 mg Part A)	sieezktjxt(jzdphvtrmu) = ulfqgqljkz dtyeyvtyjp (mgupyparqm, prheviwzjz - vaesnkbbis) View more
NCT04305587 (Phase 1, EASD2022)	Phase 1	Diabetes Mellitus, Type 2 \| Obesity	-	PF-07081532	aqywradmxv(lgginyhybq) = Most adverse events were mild and consistent with the mechanism of action. No clinically significant, adverse trends in laboratory measures, electrocardiogram or vital sign abnormalities were apparent. glhnoiorqx (gwzkzvhfub )	Positive	21 Sep 2022
NCT05158244 (Corporate Publications) Manual	Phase 1	Diabetes Mellitus, Type 2	34	PF 07081532	ufrcejrwdb(yqcrymreml) = axqlleubzo vrckmumgyq (ieltwyvyqw ) View more	Positive	10 Aug 2022
				Placebo	ufrcejrwdb(yqcrymreml) = vyqyrtdytt vrckmumgyq (ieltwyvyqw ) View more

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