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.

CTRI/2022/03/040704

/ CompletedPhase 3

A Randomized, Double-Blind, Multicentric, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Efficacy and Safety of Plecanatide in Subjects with Chronic Idiopathic Constipation or Irritable Bowel Syndrome with Constipation.

Start Date05 Mar 2022

Sponsor / Collaborator

MSN Laboratories Pvt Ltd.

100 Clinical Results associated with Plecanatide

100 Translational Medicine associated with Plecanatide

100 Patents (Medical) associated with Plecanatide

112

Literatures (Medical) associated with Plecanatide

01 Aug 2025·DRUGS

Efficacy and Safety of Plecanatide in Chinese Patients with Functional Constipation: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Article

Author: Huang, Kunming ; Lin, Lin ; Wang, Bangmao ; Zhao, Rong ; Fang, Xiangming ; Wang, Xiaoyan ; Zhen, Yanbo ; Zhang, Juan ; Ye, Bin ; Liu, Side ; Zhu, Yin ; Ma, Yingcai ; Yang, Shaoqi ; Zhou, Weizhen ; Zou, Duowu ; Wu, Jianjun ; Chen, Xi ; Yan, Peng ; Jiang, Bo ; Zhang, Xiaolan ; Wu, Yongdong ; Hou, Xiaohua ; Zhang, Heng ; Zhou, Zhongyin ; Xu, Min ; Liu, Youli ; Shi, Ruihua ; Jiang, Yueping ; Bai, Tao ; Xu, Baohong ; Zhang, Mingxin ; Ding, Xiangwu ; Zhao, Hong ; Ai, Yaowei ; Cui, Jun ; Dai, Ning ; Liao, Aijun ; Xu, Zhiyue ; Wang, Junping ; Chen, Huixin ; Zhang, Ling ; Li, Xiaoqing

BACKGROUND:

Plecanatide is a novel guanylate cyclase-C agonist for the treatment of functional constipation (FC). Its efficacy may vary across different racial populations.

OBJECTIVE:

This study aimed to comprehensively evaluate the efficacy, safety, and pharmacokinetics of plecanatide in Chinese patients with FC.

METHODS:

This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China. A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up. The primary efficacy endpoint was the durable overall complete spontaneous bowel movement (CSBM) response rate. Data on adverse events were collected. A post hoc logistic regression analysis was performed to identify predictors of durable overall CSBM response.

RESULTS:

After 12 weeks of continuous treatment, the durable overall CSBM response rates were 23.5% in the plecanatide group and 10.2% in the placebo group (p < 0.001). Plecanatide significantly increased the mean weekly frequency of CSBM (1.89 vs 0.9) and SBM (2.33 vs 1.03) compared with placebo throughout the treatment period. In addition, all other secondary efficacy endpoints showed statistically significant improvements with plecanatide compared with placebo. The most common treatment-related emergent adverse event was diarrhea, which occurred in 4.3% of plecanatide-treated patients and 0.6% of placebo-treated patients (p = 0.002). Plasma concentrations of plecanatide and its metabolite SP-338 remained below the lower limit of quantification (0.500 ng/ml) at all assessed time points. Weekly CSBM response at week 2 (odds ratio 43.476; 95% confidence interval 18.274-103.432) and baseline stool consistency (odds ratio 0.550; 95% confidence interval 0.366-0.827) were identified as effective predictors of durable overall CSBM response. Even among plecanatide non-responders, a significant improvement in SBM frequency compared with placebo was observed over the 12-week treatment period.

CONCLUSIONS:

Plecanatide 3 mg was effective and well tolerated in the treatment of Chinese patients with FC. A weekly CSBM response at week 2 may serve as a predictor of 12-week durable overall efficacy. Patients who did not achieve the primary endpoint may still benefit from plecanatide treatment.

CLINICALTRIALS:

GOV: NCT0515132.

01 May 2025·THERAPIE

Drugs and patient's dissatisfaction reporting: From a disproportionality pharmacovigilance analysis to social pharmacology

Article

Author: Montastruc, Jean-Louis

INTRODUCTION:

Patient satisfaction is a key element in medical practice. Few studies have investigated patient satisfaction or dissatisfaction with their drug treatment.

METHOD:

Using the World Health Organization (WHO) global pharmacovigilance database, we investigated, through disproportionality analyses, potential associations between exposure to drugs and "patient dissatisfaction with treatment" reports. All reports of "patient dissatisfaction with treatment" in adults until 31/12/2024 were included.

RESULTS/DISCUSSION:

Results are expressed as reporting odds ratio (ROR). Among 506 reports, three quarters came from consumers, involving mainly women aged between 45 and 64. The main coreported term was drug inefficacy (before adverse drug reactions). The first anatomical therapeutic chemical (ATC) group was dermatological drugs (25.5%) followed by alimentary tract and metabolism (24.3%), nervous system (22.5%) drugs. A significant association was found with 22 drugs with the highest ROR values for plecanatide, efinaconazole and avatrombopag.

CONCLUSION:

Despite its mandatory limitations (underreporting, selective reporting…), this study shows that pharmacovigilance data could help to understand some aspects of social pharmacology, here, patient dissatisfaction with their drug treatment.

01 May 2025·ADVANCES IN THERAPY

Healthcare Utilization and Costs of Care in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation After Initiating Oral Therapies: Real-World Analysis in the US Medicare Population

Article

Author: Kort, Jens ; Boules, Mena ; Lee, Tsung-Ying ; Ando, Masakazu ; Baldwin, Zachary ; Shah, Eric ; Sanchez Gonzalez, Yuri ; Champaloux, Steven W

INTRODUCTION:

Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common functional intestinal disorders which impact all age groups, yet there is limited comparative evidence on the economic benefits of treatment of these conditions on the elderly. We assessed differences in healthcare resource utilization (HCRU) and total costs of care among Medicare-insured patients initiating linaclotide, lubiprostone, or plecanatide after 1 year.

METHODS:

Retrospective analysis from the Merative™ MarketScan^® Medicare Database (January 2017-September 2023), including adult patients who initiated a qualifying IBS-C/CIC medication (linaclotide, lubiprostone, plecanatide) (index date defined as date of initiation) and had at least 6 months of pre-index and 12 months of post-index continuous benefit coverage under fee-for-service Medicare plans. For HCRU and all-cause total cost (medical + pharmacy) outcomes, 12-month comparisons were characterized via count (for HCRU) or cost ratios between linaclotide and lubiprostone, and linaclotide and plecanatide. Generalized linear regression models adjusting for key baseline patient characteristics and 6-month pre-index HCRU and cost were used to estimate differences in outcomes at 12 months between treatment groups.

RESULTS:

A total of 7916 Medicare patients were included in the analysis, of whom 5773 initiated linaclotide, 1856 initiated lubiprostone, and 287 initiated plecanatide. After adjusting for key patient characteristics and pre-index HCRU, count ratios > 1 demonstrated that patients who received lubiprostone versus linaclotide had significantly greater HCRU (P < 0.05) at 12 months. After 12 months follow-up, adjusted all-cause total costs of care were significantly lower among patients who received linaclotide versus lubiprostone or plecanatide, largely driven by lower all-cause medical costs observed in patients who received linaclotide (P < 0.05).

CONCLUSION:

These findings suggest that linaclotide treatment may be associated with lower total healthcare costs compared to lubiprostone and plecanatide for patients initiating IBS-C/CIC-related drugs in Medicare populations.

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

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02493452 \| NCT02387359 \| NCT01982240 \| NCT02122471 (Pubmed \| Neurogastroenterol Motil)	Phase 3	Chronic idiopathic constipation \| Irritable bowel syndrome with constipation	4,815	Plecanatide 3 mg	cwkcntdbly(fdwlplmikv) = iwlhbifmmh pahnalpbpy (vzdojwmqla ) View more	Positive	01 Sep 2023
				Plecanatide 6 mg	cwkcntdbly(fdwlplmikv) = clerdelbac pahnalpbpy (vzdojwmqla ) View more
UEGW2020	Not Applicable	Irritable bowel syndrome with constipation	-	Plecanatide 3 mg	kzzlaafpoa(dbksgtityu) = ijmbdanssg kvkxizmfny (ailpjzfgtv ) View more	-	11 Oct 2020
				Plecanatide 6 mg	kzzlaafpoa(dbksgtityu) = zepigmtmbc kvkxizmfny (ailpjzfgtv ) View more
NCT02706483 (IBS-C, CTgov)	Phase 3	Irritable bowel syndrome with constipation	2,272	Plecanatide	kvlkjveasp = gkymjnozcn wfeakjaifv (bmkgtqjpeo, bcicneprko - beekjplncg) View more	-	18 Aug 2020
NCT01053962 (CIC, CTgov)	Phase 2	Chronic idiopathic constipation	84	SP-304 0.3 mg (SP-304 0.3 mg)	iwcsxfgxtl = hvnfasklly xydgletfsi (hkveitxrlc, srbzhuqjue - choxdidsnj) View more	-	02 Jan 2020
				SP-304 1.0 mg (SP-304 1.0 mg)	iwcsxfgxtl = yjtledoayl xydgletfsi (hkveitxrlc, nrwfnbhlgh - lfmquasnii) View more
NCT03120520 (CTgov)	Phase 2	Chronic idiopathic constipation	124	Matching placebo (Matching Placebo)	bhjhenigsh = pzhwoliycw sgfnwqtufc (hainqzlutz, wnkzxjeiny - pzivmddlet) View more	-	19 Sep 2019
				Plecanatide (Plecanatide 0.5 mg)	bhjhenigsh = nxrjykzxyp sgfnwqtufc (hainqzlutz, rdhcihxgfo - kmzfhhzkgj) View more
NCT01919697 (CTgov)	Phase 3	Chronic idiopathic constipation	2,370	Plecanatide (Plecanatide 3 mg)	txhjirjjed = vpbtfrrdcw tvfihbomms (dpuicvofrt, kywnhkcwxc - difsndktaj) View more	-	02 Jul 2019
				Plecantide (Plecantide 6 mg)	txhjirjjed = xacxqzmoou tvfihbomms (dpuicvofrt, njawsidysc - gqyhqsfqzk) View more
NCT02493452 (IBS-C, CTgov)	Phase 3	Irritable bowel syndrome with constipation	1,135	Placebo (Matching Placebo)	stsunkcowh = fjcwvycexd oopfzethsh (jaauyoxwoi, qbusseeaac - pqptvnipgg) View more	-	14 Jun 2019
				Plecanatide (3.0 mg Plecanatide)	stsunkcowh = fmrppnvphk oopfzethsh (jaauyoxwoi, lucgekiynq - myznmfrsgy) View more
NCT02387359 (IBS-C, CTgov)	Phase 3	Constipation \| Irritable bowel syndrome with constipation	1,054	Placebo (Matching Placebo)	owwzqrtzjh = jlrrlmrvgc vrztnvejzp (ondpknwgus, zhovpvxqqp - bswdknrsiq) View more	-	14 Jun 2019
				Plecanatide (3.0 mg Plecanatide)	owwzqrtzjh = nmbfpmhxnw vrztnvejzp (ondpknwgus, jyspcdtfsr - brsxlwelau) View more
NCT01982240 (CTgov)	Phase 3	Chronic idiopathic constipation	1,394	Placebo (Placebo)	bjodsuqtpc = eiclzxazkq fjeujlafux (vahhxljzcq, fpjgmbeyod - sqcqyjwepi) View more	-	21 Mar 2019
				Plecanatide (Plecanatide 3.0 mg)	bjodsuqtpc = floujshjdt fjeujlafux (vahhxljzcq, xlpmiubqts - suayhdmzgw) View more
NCT02122471 (CIC, CTgov)	Phase 3	Chronic idiopathic constipation	1,410	Placebo	hkosgqyzfq = rfczqwrqoh unpbhkghro (ovmtetkcyb, qkmrzctckt - lybwwhufiq) View more	-	14 Mar 2019

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