A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)

The goal of this clinical trial is to learn if plecanatide can treat functional constipation in children and adolescents aged 6 to less than 18 years. It will also learn about the safety and pharmacokinetics of plecanatide in this population. The main questions it aims to answer are:
* Does plecanatide increase the number of spontaneous bowel movements compared to placebo after 8 weeks of treatment?
* What medical problems do participants experience when taking plecanatide? Researchers will compare low-dose plecanatide and high-dose plecanatide to placebo to see if plecanatide improves bowel movement frequency, stool consistency, and constipation-related symptoms.
Participants will:
* Complete a screening period with daily electronic diary entries to record bowel movements, symptoms, and rescue medication use
* Take plecanatide or placebo by mouth once daily for 8 weeks
* Continue daily electronic diary entries throughout the study
* Attend clinic visits for physical exams, laboratory tests, and assessments of symptoms and safety
* Provide blood samples for pharmacokinetic and safety evaluations
* Complete questionnaires about constipation symptoms and quality of life

Start Date01 Jun 2026

Sponsor / Collaborator

Bausch Health Americas, Inc.

NCT05107219

/ CompletedPhase 1IIT

Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers

This early phase I trial studies the guanylyl cyclase C (GCC) agonist effect on cGMP signal in duodenal tissue. Plecanatide and linaclotide are drugs approved by the Food and Drug Administration for the treatment of conditions related to constipation. This trial aims to see the effects of taking either one of two drugs, plecanatide or linaclotide, or no drug, on a certain chemical found in the tissue collected from small intestine and how they compare.

Start Date30 Nov 2022

Sponsor / Collaborator

University of Wisconsin-Madison

[+1]

NCT05151328

/ CompletedPhase 3

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 Weeks

This is a multi-center, randomized, double-blind, Placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Plecanatide in the treatment of Functional Constipation in Chinese patients for up to 12 weeks.
Patients will enter a Screening period which must undergo a 2-week Pre-Treatment assessment, they will complete daily assessments of electronic dairy to demonstrate the eligibility.
Eligible subjects will be randomized into Plecanatide 3 mg group or Placebo group at Visit 1 at the ratio of 1:1 and take an oral dose of study treatment continuously for 12 weeks. For 2 weeks after complete dosing patients will continue to complete daily electronic dairy. Patients will then return to the clinical site for efficacy and safety assessment as part of an End of Study visit. The planned duration of participation in this study will be 154 days and up to 164 days with all windows considered.

Start Date18 Mar 2022

Sponsor / Collaborator

Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.

100 Clinical Results associated with Plecanatide

100 Translational Medicine associated with Plecanatide

100 Patents (Medical) associated with Plecanatide

114

Literatures (Medical) associated with Plecanatide

01 Aug 2026·JOURNAL OF CHROMATOGRAPHY A

A targeted partial reduction cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in disulfide rich cyclic peptides

Article

Author: Sharma, Nitish ; Chaturvedi, Sachin ; Sneha, Kumari

Determining disulfide bridge connectivity in disulfide rich peptides presents significant analytical challenges, primarily due to the presence of isobaric species that cannot be distinguished by intact mass analysis alone. This study describes a targeted approach based on controlled partial reduction followed by cyanylation for the reliable assignment of disulfide linkages. The method was evaluated using representative approved cyclic peptide therapeutics, specifically Linaclotide, Plecanatide, and Ziconotide. These peptides were selected as model due to their clinical relevance, well-defined and diverse disulfide bond architectures, and their status as benchmark examples of disulfide-rich therapeutics. Partial reduction was optimized to generate mono-reduced intermediates, which were subsequently derivatized through cyanylation. This modification enabled selective cleavage at cysteine residues, producing structurally informative fragments after final reduction. These fragments were characterized using high-resolution mass spectrometry (HRMS), facilitating clear identification of disulfide connectivity. The proposed workflow demonstrates high reproducibility and analytical consistency, with excellent mass accuracy and enhanced structural resolution relative to conventional methodologies. Notably, it enables reliable differentiation of disulfide isomers that are otherwise indistinguishable using routine analytical techniques. Overall, this study establishes a practical and robust method for disulfide bond mapping in cyclic peptides, with broad applicability for structural characterization and quality assessment and don't require enzymatic digestion or specialized instrumentation.The methodology was successfully validated using Linaclotide, Plecanatide, and Ziconotide, which contain three, two, and three disulfide bridges, respectively.

01 Apr 2026·HOSPITAL PHARMACY

Based on the FDA Adverse Event Reporting System Database, a Study on Signal Mining of Adverse Events for Guanylate Cyclase-C Receptor Agonists

Article

Author: Guo, Chiwei ; Lei, Da ; Zhao, Shujuan

Objective::

To analyze and evaluate adverse drug event (ADE) signals for two GC-C receptor agonists, Linaclotide and Plecanatide, thereby enhancing understanding of their clinical safety.

Methods::

Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023. Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).

Results::

A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs). Both drugs predominantly exhibited gastrointestinal ADEs, including abdominal pain, bloating, and diarrhea. Linaclotide was associated with signals for urinary retention, incontinence, and bladder pain, which are not documented in its prescribing information. Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions. Additionally, both drugs revealed signals related to water and electrolyte disorders.

Conclusion::

Clinical utilization of GC-C receptor agonists should take into account not only the prevalent gastrointestinal ADEs but also emerging signals associated with the urinary system, metabolic and nutritional disorders, and the nervous system. A comprehensive understanding of these signals is essential for evaluating medication risks and ensuring appropriate drug administration.

01 Mar 2026·AMERICAN JOURNAL OF GASTROENTEROLOGY

The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

Review

Author: Busam, Jonathan A. ; Pimentel, Mark ; Rezaie, Ali ; Marshall, Caroline ; Joo, LiJin ; Batta, Nisha ; Shah, Eric D.

INTRODUCTION::

Understanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.

METHODS::

PubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.

RESULTS::

Fifty-four trials met inclusion criteria. For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 ( P < 0.01), 53 ( P = 0.59), 59 ( P < 0.01), 58 ( P = 0.03), and 16 ( P < 0.01), respectively. For diarrhea-predominant IBS pharmacotherapies, the NNH for alosetron and eluxadoline was 14 ( P < 0.01) and 32 ( P < 0.01) whereas the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value. For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 ( P < 0.01). Many AEs were transient without long-term sequela.

DISCUSSION::

Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.

News (Medical) associated with Plecanatide

29 Aug 2025

·www.einpresswire.com

January - March 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include hypersensitivity reactions. Addyi labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua (insulin glargine and lixisenatide) Trulicity (dulaglutide) Victoza (liraglutide) Xultophy (insulin degludec and liraglutide) Drug-induced liver injury The "Adverse Reactions" section of the liraglutide and dulaglutide labeling was updated in June 2022 to include information about elevations of liver enzymes. Example: Trulicity labeling FDA determined that no action is necessary at the time for lixisenatide, exenatide, and semaglutide based on available information. Alcohol-based hand sanitizers Exposure via inhalation FDA determined that no action is necessary at the time based on available information. A FDA Drug Safety Communication was issued on June 16, 2021. Amlodipine and Levamlodipine Products Azor (amlodipine and olmesartan medoxomil ) Caduet (amlodipine besylate and atorvastatin calcium) Conjupri (levamlodipine maleate) Consensi (amlodipine besylate and celecoxib) Exforge (amlodipine and valsartan) Exforge HCT (amlodipine/valsartan and hydrochlorothiazide) Lotrel (amlodipine besylate and benazepril hydrochloride) Katerzia (amlodipine benzoate) Norvasc (amlodipine besylate) Prestalia (amlodipine besylate and perindopril arginine) Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide) Twynsta (amlodipine and telmisartan) Non-cardiogenic pulmonary edema FDA determined that no action is necessary at the time based on available information. Avonex (interferon beta-1a) Betaseron (interferon beta-1b) Extavia (interferon beta-1b) Plegridy (pegylated interferon beta-1a) Rebif (interferon beta-1a) Injection site abscess FDA is evaluating the need for regulatory action. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Scleroderma FDA determined that no action is necessary at the time based on available information. Bavencio (avelumab) Imfinzi (durvalumab) Keytruda (pembrolizumab) Libtayo (cemiplimab-rwlc) Opdivo (nivolumab) Tecentriq (atezolizumab) Cholangitis sclerosing The "Adverse Reactions" section of the Keytruda (pembrolizumab) labeling was updated in August 2021 to include sclerosing cholangitis. Example: Keytruda labeling FDA determined that no action is necessary at the time for Bavencio (avelumab), Imfinzi (durvalumab), Libtayo (cemiplimab-rwlc), Opdivo (nivolumab), and Tecentriq (atezolizumab) based on available information. Chloroquine Generic products containing chloroquine Phospholipidosis The “Warnings” section of the labeling was updated in May 2022 to include information about phospholipidosis. Eliquis (apixaban) Pradaxa (dabigatran etexilate mesylate) Savaysa (edoxaban tosylate) Xarelto (ribaroxaban) Generic products containing dabigatran etexilate mesylate Generic products containing ribaroxaban Menorrhagia The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential. Eliquis label Pradaxa label Savaysa label Xarelto label Depakote (divalproex sodium) Depakote ER (divalproex sodium) Stavzor (valproic acid) Generic products containing divalproex sodium Generic products containing valproic acid Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated in November 2021 to include tubulointerstitial nephritis. Example: Depakote labeling Dupixent (dupilumab) Alopecias FDA is evaluating the need for regulatory action. H.P. Acthar Gel (corticotropin) Anaphylactic and anaphylactoid responses The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include anaphylaxis. Acthar Gel labeling H.P. Acthar Gel (corticotropin) Cardiac arrhythmias The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in October 2021 to include atrial fibrillations and palpitations. Acthar Gel labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Verzenio (abemaciclib) Second primary malignancy FDA determined that no action is necessary at the time based on available information. Lynparza (olaparib) Drug-induced liver injury FDA determined that no action is necessary at the time based on available information. Ocrevus (ocrelizumab) Autoimmune colitis The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Medication Guide" sections of the labeling were updated in August 2022 to include colitis. Ocrevus labeling Poteligeo (mogamulizumab-kpkc) Acute kidney injury The "Warnings and Precautions" section of the labeling was updated in March 2022 to include glomerulonephritis. Poteligeo labeling Ravicti (glycerol phenylbutyrate) Product labeling issue regarding stability and instructions for administration The container label, carton label, "Medication Guide", and sections of the Prescribing Information ("Dosage and Administration" and "Patient Counseling Information") were updated in September 2021 to enhance the instructions for administration. Ravicti labeling Spravato (esketamine) Hypertensive crisis FDA determined that no action is necessary at the time based on available information. Tremfya (guselkumab) Device use errors resulting in possible missed or partial doses The Tremfya One Press Instructions for Use (IFU) and carton labeling was updated in June 2023 to mitigate medication errors, such as underdose or no dose delivered. Tremfya labeling Trulance (plecanatide) Drug hypersensitivity The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash. Trulance Label Trulance (plecanatide) Vomiting The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting. Trulance Label Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug Approval

01 Aug 2024

·ir.bauschhealth.com

Bausch Health Announces Second Quarter 2024 Results

Second quarter consolidated revenues of $2.40 billion, up 11% on a Reported and 8% on an Organic (non-GAAP)1 basis Consolidated GAAP Net Income Attributable to Bausch Health Companies Inc. of $10 million Consolidated Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $798 million, up 10% Raising consolidated full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance LAVAL, QC, August 1, 2024 – Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its second quarter 2024 financial results and other key updates from the quarter. "We continued our momentum in the second quarter, delivering our fifth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA, underscoring the strength of our product and geographic footprint and reinforcing our strategy. We remain focused on advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive growth globally. I'm proud of the hard work and accomplishments of our team, who work tirelessly to improve the health of patients worldwide," said Thomas J. Appio, Chief Executive Officer, Bausch Health. Second Quarter 2024 Revenue Performance Total consolidated reported revenues were $2.40 billion for the second quarter of 2024, compared with $2.17 billion in the second quarter of 2023, an increase of $236 million, or 11%. Excluding the impact of foreign exchange of $25 million, acquisitions of $104 million, and divestitures and discontinuations of $14 million, revenue increased by 8% organically1 compared with the second quarter of 2023. Reported revenues by segment were as follows: Three Months Ended June 30, Reported Change Change at Constant Currency1 (Non-GAAP) Change in Organic Revenue1 (Non-GAAP) (in millions) 2024 2023 Amount Pct. Total Bausch Health Revenues $2,403 $2,167 $236 11% 12% 8% Bausch Health (excl. B+L) $1,187 $1,132 $55 5% 5% 6% Salix segment $558 $557 $1 —% —% 1% International segment $276 $259 $17 7% 5% 6% Solta Medical segment $102 $88 $14 16% 19% 19% Diversified segment $251 $228 $23 10% 10% 12% Bausch + Lomb segment $1,216 $1,035 $181 17% 20% 10% Salix Segment Salix segment reported revenues were $558 million for the second quarter of 2024, compared with $557 million for the second quarter of 2023. Excluding the impact of divestitures and discontinuations of $5 million, segment revenues increased 1% on an organic1 basis. Xifaxan® revenues grew 10% compared with the second quarter of 2023, which was offset by declines in Relistor®, Trulance®, and certain non-promoted products. International Segment International segment reported revenues were $276 million for the second quarter of 2024, compared with $259 million for the second quarter of 2023, an increase of $17 million, or 7%. Excluding the impact of foreign exchange of $5 million and divestitures and discontinuations of $3 million, segment revenues increased organically1 by 6% compared with the second quarter of 2023, led by double-digit growth in Canada and solid growth in Latin America. Solta Medical Segment Solta Medical segment reported revenues were $102 million for the second quarter of 2024, compared with $88 million in the second quarter of 2023, an increase of $14 million, or 16%, which was driven by growth in Asia-Pacific, led by South Korea. Excluding the impact of foreign exchange of $3 million, segment revenues increased organically1 by 19% compared with the second quarter of 2023. Diversified Segment Diversified segment reported revenues were $251 million for the second quarter of 2024, compared with $228 million for the second quarter of 2023, an increase of $23 million, or 10%. Excluding the impact of divestitures and discontinuations of $4 million, segment revenues increased 12% on an organic1 basis, primarily attributable to increases in sales in Dermatology and Neurology. Bausch + Lomb Segment Bausch + Lomb segment reported revenues were $1,216 million for the second quarter of 2024, compared with $1,035 million for the second quarter of 2023, an increase of $181 million, or 17%. Excluding the impact of foreign exchange of $27 million, acquisitions of $104 million and divestitures and discontinuations of $2 million, the Bausch + Lomb segment revenues increased organically1 by 10% compared with the second quarter of 2023, driven by increases across all business units. 1 This is a non-GAAP measure or a non-GAAP ratio. For further information on non-GAAP measures and non-GAAP ratios, please refer to the "Non-GAAP Information" section of this news release. Please also refer to tables at the end of this news release for a reconciliation of this and other non-GAAP measures and ratios to the most directly comparable GAAP measure. Read More View original release here: https://www.accesswire.com/viewarticle.aspx?id=894962

Financial StatementAcquisition

28 Jun 2024

·www.biospace.com

Ardelyx Presents Additional Data Detailing Educational Needs Related to IBS-C Management Across Healthcare Disciplines

WALTHAM, Mass., June 28, 2024 (GLOBE NEWSWIRE) -- Ardelyx Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that data detailing educational needs related to irritable bowel syndrome with constipation (IBS-C) across healthcare disciplines was presented via a poster at the 2024 American Association of Nurse Practitioners (AANP) Annual Conference, currently taking place in Nashville, Tennessee. Poster IND #37, entitled “Educational Needs Related to Irritable Bowel Syndrome with Constipation (IBS-C) Management Across Disciplines: a Comparison of Nurse Practitioners, Physician Assistants, and Physicians” includes findings from a case-based survey involving 410 cross-disciplinary healthcare professionals (HCPs) and sheds light on practice differences and educational requirements related to the diagnosis and management of IBS-C. The data reveals notable differences between nurse practitioners (NPs)/physician assistants (PAs) and physicians, particularly in their choice of IBS-C diagnostic criteria and testing methodologies, tendency to refer patients to specialists and approach to assessing pain levels. It also shows that gastroenterology HCPs are more likely to prescribe linaclotide, plecanatide or tenapanor for IBS-C patients who avoid social events due to discomfort, whereas primary care physicians are more likely to prescribe neuromodulators. These findings show the importance of tailoring educational initiatives to meet the specific needs of different clinical specialties and roles within the healthcare landscape. About Irritable Bowel Syndrome with Constipation (IBS-C) Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden. IMPORTANT SAFETY INFORMATION WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age. The safety and effectiveness of IBSRELA have not been established in patients less than 18 years of age. CONTRAINDICATIONS IBSRELA is contraindicated in: patients less than 6 years of age due to the risk of serious dehydration patients with known or suspected mechanical gastrointestinal obstruction WARNINGS AND PRECAUTIONS Risk of Serious Dehydration in Pediatric Patients IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years). Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Diarrhea Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. MOST COMMON ADVERSE REACTIONS The most common adverse reactions in IBSRELA-treated patients (incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4% placebo), abdominal distension (3% vs <1%), flatulence (3% vs 1%) and dizziness (2% vs <1%). INDICATION IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults. Please see full Prescribing Information, including Boxed Warning, for additional risk information. About Ardelyx Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. For more information, please visit and connect with us on X (formerly known as Twitter), LinkedIn and Facebook. Investor and Media Contacts: Caitlin Lowie clowie@ardelyx.com

Drug Approval

100 Deals associated with Plecanatide

External Link

KEGG	Wiki	ATC	Drug Bank
D09948	Plecanatide	A06AX07	DB13170

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Irritable Bowel Syndrome	Canada	Bausch Health Cos., Inc.	12 Jan 2022
Irritable bowel syndrome with constipation	United States	Salix Pharmaceuticals, Inc.	24 Jan 2018
Chronic idiopathic constipation	United States	Salix Pharmaceuticals, Inc.	19 Jan 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Constipation - functional	Phase 3	China	Salix Pharmaceuticals, Inc.	03 Mar 2022
Constipation - functional	Phase 3	China	Shandong Luoxin Pharmaceutical Group Stock Co., Ltd.	03 Mar 2022
Constipation	Phase 3	United States	Bausch Health Americas, Inc.	01 Dec 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02493452 \| NCT02387359 (Pubmed \| J Gastroenterol Hepatol)	Phase 3	Irritable Bowel Syndrome	605	Plecanatide 3 mg	uepbtlsoeu(tdnhpntcaw) = Plecanatide/placebo baseline mean symptom scores were 6.2/6.4 for abdominal pain and 6.4/6.6 for bloating; both had a mean of 0.2 CSBMs/week. ejgeeihyxl (rqslknbgef ) View more	Positive	10 Nov 2025
				Placebo
NCT02493452 \| NCT02387359 \| NCT01982240 \| NCT02122471 (Pubmed \| Neurogastroenterol Motil)	Phase 3	Chronic idiopathic constipation \| Irritable bowel syndrome with constipation	4,815	Plecanatide 3 mg	utwwcpjxyv(diozrzmxka) = uvkjyzhgxr ztozhmzody (vvnaygtwrc ) View more	Positive	01 Sep 2023
				Plecanatide 6 mg	utwwcpjxyv(diozrzmxka) = kjjcztiavf ztozhmzody (vvnaygtwrc ) View more
UEGW2020	Not Applicable	Irritable bowel syndrome with constipation	-	Plecanatide 3 mg	uafmnmpcnt(luwzpqujau) = aymjoztchg nydjmningx (kfevfbiats ) View more	-	11 Oct 2020
				Plecanatide 6 mg	uafmnmpcnt(luwzpqujau) = rdpraykyck nydjmningx (kfevfbiats ) View more
NCT02706483 (IBS-C, CTgov)	Phase 3	Irritable bowel syndrome with constipation	2,272	Plecanatide	mcektdlnsw = vwupbtvdkx thjsnfhmnj (yqdjuxqrxg, jgivnjscbl - uetatfiunc) View more	-	18 Aug 2020
NCT01053962 (CIC, CTgov)	Phase 2	Chronic idiopathic constipation	84	SP-304 0.3 mg (SP-304 0.3 mg)	czatnxehlf = ovpeveaqka dyeqojwixo (mzwanmtjvr, difxayfqvt - monbzttwbk) View more	-	02 Jan 2020
				SP-304 1.0 mg (SP-304 1.0 mg)	czatnxehlf = iasxsqdkss dyeqojwixo (mzwanmtjvr, wixktkjmpw - rclzsyeuyw) View more
NCT03120520 (CTgov)	Phase 2	Chronic idiopathic constipation	124	Matching placebo (Matching Placebo)	tlebqeahuw = fmyylntrya sleiofojyt (kvsvvidwyn, miimglstzt - krtabroemd) View more	-	19 Sep 2019
				Plecanatide (Plecanatide 0.5 mg)	tlebqeahuw = hgoacvurmi sleiofojyt (kvsvvidwyn, dxvxobewdj - uonvurmhev) View more
NCT01919697 (CTgov)	Phase 3	Chronic idiopathic constipation	2,370	Plecanatide (Plecanatide 3 mg)	nysexsjlnd = ghzfcmpioi nslylbbpmf (znmaxckxag, tsaaxucjxa - btcnkynsne) View more	-	02 Jul 2019
				Plecantide (Plecantide 6 mg)	nysexsjlnd = moybrtofvt nslylbbpmf (znmaxckxag, bsoksnwunn - jaixzglykm) View more
NCT02493452 (IBS-C, CTgov)	Phase 3	Irritable bowel syndrome with constipation	1,135	Placebo (Matching Placebo)	mgdwszkqwi = pxdkhtkqip zsvzfaiays (sekkximpee, ibsjiwqnqj - nfuhejgxfu) View more	-	14 Jun 2019
				Plecanatide (3.0 mg Plecanatide)	mgdwszkqwi = pxrbtjiecj zsvzfaiays (sekkximpee, tnyrmfbocw - jqujbhywfi) View more
NCT02387359 (IBS-C, CTgov)	Phase 3	Constipation \| Irritable bowel syndrome with constipation	1,054	Placebo (Matching Placebo)	mhjahfxlfg = oajavwhuch keuugnlsej (ghxzzuxazw, szmgbrvole - weamcbvfup) View more	-	14 Jun 2019
				Plecanatide (3.0 mg Plecanatide)	mhjahfxlfg = gmxzeogeti keuugnlsej (ghxzzuxazw, xhlcwraczy - kwkpdtxgtg) View more
NCT01982240 (CTgov)	Phase 3	Chronic idiopathic constipation	1,394	Placebo (Placebo)	lvxfnxbefr = hsasinduyn ynrfvcnlrk (mjsqnwdvkg, dgobsuylbz - wocopqiztg) View more	-	21 Mar 2019
				Plecanatide (Plecanatide 3.0 mg)	lvxfnxbefr = sbecyoahtw ynrfvcnlrk (mjsqnwdvkg, xrpbsullik - zkqtnfhlej) View more

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis