This is a study to determine if a certain drug, called telotristat ethyl (Xermelo®), can help reduce the chance of blood pressure and heart rate variations (known as carcinoid crisis) in individuals who have neuroendocrine tumors (also called carcinoid tumors). These complications can be life-threatening for patients who already have to experience challenging surgeries to remove their tumors. To determine if telotristat ethyl (Xermelo®) will help reduce these complications during surgery, researchers will give the drug to study participants before surgery.

Start Date01 Jan 2022

Sponsor / Collaborator

The University of Chicago

NCT04810091 / RecruitingPhase 3IIT

TELEHEART: Telotristat Ethyl in a Heart Biomarker Study

This phase III trial compares the effect of telotristat ethyl and the current standard of care somatostatin analog therapy or somatostatin analog therapy alone in treating patients with neuroendocrine tumor that has spread to other places in the body (metastatic). Telotristat ethyl and somatostatin analog therapy may help to control carcinoid syndrome and carcinoid heart disease.

Start Date18 May 2021

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

NCT04713202 / WithdrawnPhase 2

Prospective Assessment of Patients With Neuroendocrine Tumors and Current or Prior History of Carcinoid Syndrome or Diarrhea Undergoing Peptide Receptor Radionuclide Therapy With or Without Telotristat Ethyl (NET-PACS Trial) Big Ten Cancer Research Consortium BTCRC-GI19-400

The NET-PACS trial is a Prospective Assessment of patients with neuroendocrine tumors and current or prior history of Carcinoid Syndrome or diarrhea undergoing peptide receptor radionuclide therapy with or without telotristat ethyl. The main goal of the study is to demonstrate the feasibility of serial in-depth assessment of patients with neuroendocrine tumors and current or prior history of carcinoid syndrome or diarrhea undergoing treatment with PRRT using telotristat ethyl compared to placebo. We aim to report and describe from a patient's perspective the multi-faceted impact of carcinoid syndrome in patients with NETs and the changes on treatment while getting PRRT using telotristat ethyl compared to placebo.

Start Date03 Mar 2021

Sponsor / Collaborator-

100 Clinical Results associated with Telotristat Etiprate

100 Translational Medicine associated with Telotristat Etiprate

100 Patents (Medical) associated with Telotristat Etiprate

Literatures (Medical) associated with Telotristat Etiprate

31 Dec 2023·Oncoimmunology

Increased tryptophan, but not increased glucose metabolism, predict resistance of pembrolizumab in stage III/IV melanoma

Article

Author: Thomas, Nancy E ; Ezzell, Jennifer A ; Li, Zibo ; Ollila, David W ; Bouchard, Deeanna M ; Ivanovic, Marija ; Oldan, Jorge D ; Meyers, Michael O ; Long, Patricia K ; Lee, Yueh Z ; Trembath, Dimitri G ; Smith, Eric ; Zhao, Weiling ; Nikolaishvili-Feinberg, Nana ; Wong, Terence Z ; Giglio, Benjamin C ; Moschos, Stergios J ; Collichio, Frances A ; Ivanova, Anastasia ; Abernethy-Leinwand, Amber ; Kowalski, Madeline H ; Wallack, Diana E ; Googe, Paul B

Clinical trials of combined IDO/PD1 blockade in metastatic melanoma (MM) failed to show additional clinical benefit compared to PD1-alone inhibition. We reasoned that a tryptophan-metabolizing pathway other than the kynurenine one is essential. We immunohistochemically stained tissues along the nevus-to-MM progression pathway for tryptophan-metabolizing enzymes (TMEs; TPH1, TPH2, TDO2, IDO1) and the tryptophan transporter, LAT1. We assessed tryptophan and glucose metabolism by performing baseline C11-labeled α-methyl tryptophan (C11-AMT) and fluorodeoxyglucose (FDG) PET imaging of tumor lesions in a prospective clinical trial of pembrolizumab in MM (clinicaltrials.gov, NCT03089606). We found higher protein expression of all TMEs and LAT1 in melanoma cells than tumor-infiltrating lymphocytes (TILs) within MM tumors (n = 68). Melanoma cell-specific TPH1 and LAT1 expressions were significantly anti-correlated with TIL presence in MM. High melanoma cell-specific LAT1 and low IDO1 expression were associated with worse overall survival (OS) in MM. Exploratory optimal cutpoint survival analysis of pretreatment 'high' vs. 'low' C11-AMT SUV_max of the hottest tumor lesion per patient revealed that the 'low' C11-AMT SUV_max was associated with longer progression-free survival in our clinical trial (n = 26). We saw no such trends with pretreatment FDG PET SUV_max. Treatment of melanoma cell lines with telotristat, a TPH1 inhibitor, increased IDO expression and kynurenine production in addition to suppression of serotonin production. High melanoma tryptophan metabolism is a poor predictor of pembrolizumab response and an adverse prognostic factor. Serotoninergic but not kynurenine pathway activation may be significant. Melanoma cells outcompete adjacent TILs, eventually depriving the latter of an essential amino acid.

05 Jul 2023·The oncologist

Carcinoid Heart Disease Management: A Multi-Disciplinary Collaboration.

Article

Author: Das, Satya ; Hassan, Saamir A ; Stockton, Shannon S

Carcinoid heart disease (CaHD) is an important complication among patients with metastatic neuroendocrine tumors and carcinoid syndrome (CS). CS patients (25%-65%) eventually develop CaHD; these patients face a significantly increased risk of morbidity and mortality. Guidance papers (eg, clinical practice guidelines, consensus guidelines, and expert statements) have been established by major organizations across the disciplines of cardiology and oncology; however, these recommendations are not routinely implemented. The aim of this article is to encourage the integration of current recommendations from national societies into clinical practice. Early screening upon recognition of CS and prior to the development of CaHD symptoms is paramount, as no existing therapies are approved to reverse the fibrotic damage to the heart once it occurs. Valvular replacement is the only definitive treatment for CaHD once it has developed. When patients are noted to have urinary 5-hydroxyindoleacetic acid (5-HIAA) levels ≥300 µmol/24 h and/or serum N-terminal pro B-type natriuretic peptide (NT-proBNP) levels >260 pg/mL, echocardiography is recommended. Systemic approaches to control tumor growth and hormonal secretion include somatostatin analogs (SSAs), followed by options including peptide receptor radiotherapy (PRRT), everolimus and liver embolization. Telotristat is the primary choice for control of diarrhea refractory to SSA. Diuretics are the mainstay of heart failure symptom management for patients who develop CaHD. Considerations for future research are discussed, including the ongoing TELEHEART (TELotristat Ethyl in a HEART biomarker study) trial involving telotristat and not yet activated CHARRT (Carcinoid Heart disease And peptide Receptor Radiotargetted Therapy) study involving PRRT with lutetium 177 (177Lu) dotatate.

20 Apr 2023·Endocrine oncology (Bristol, England)

The role of serotonin inhibition within the treatment of carcinoid syndrome

Review

Author: White, Benjamin ; Srirajaskanthan, Rajaventhan ; George, Joel ; Ramage, John

Carcinoid syndrome is the most frequent hormonal complication associated with neuroendocrine neoplasms. It was first reported in 1954, and the classical symptoms are diarrhoea, flushing and abdominal pain. It is caused by the secretion of several vasoactive substances, the most prominent being serotonin, which play a pathophysiological role in the clinical symptoms which characterise carcinoid syndrome. Therefore, the focus of carcinoid syndrome treatment is to reduce serotonin production and hence improve the patient’s quality of life. There are a variety of management options for carcinoid syndrome including medical, surgical and loco-regional interventional radiological procedures. The most widely used are somatostatin analogues with three clinically approved drugs: lanreotide and octreotide (first-generation) and pasireotide (second-generation). Both everolimus and interferon used in combination with octreotide have shown significant reduction in urinary 5-hydroxyindoleacetic acid compared to octreotide alone. Telotristat ethyl has been increasingly utilised for patients with symptoms despite taking somatostatin analogues. It has also been shown to have a significant improvement in bowel movement frequency which was associated with a significant improvement in quality of life. Peptide receptor radionuclide therapy has proven symptomatic improvement in patients with uncontrolled symptoms. Chemotherapy is primarily reserved for patients with high proliferation tumours, with limited research on the efficacy in reducing symptoms. Surgical resection remains the optimal treatment due to being the only one that can achieve a cure. Liver-directed therapies are considered in patients where curative resection is not possible. There are therefore numerous different therapies. This paper describes the pathophysiology and therapy of carcinoid syndrome.

News (Medical) associated with Telotristat Etiprate

07 Dec 2022

·www.prnewswire.com

TerSera® to sponsor "NET Cancer Health Storylines" digital platform to support patients suffering from Carcinoid Syndrome Diarrhea

DEERFIELD, Ill., Dec. 7, 2022 /PRNewswire/ -- TerSera Therapeutics announced today a new sponsorship with the Carcinoid Cancer Foundation (CCF) and Alira Health to expand and optimize a holistic patient journey digital platform for patients with Neuroendocrine Tumors and Carcinoid Syndrome. Carcinoid syndrome (CS) is a rare condition that occurs in patients living with metastatic neuroendocrine tumors (mNETs) and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives. Other symptoms of CS include facial flushing, abdominal pain, fatigue and, over time, for some people, heart valve damage.1-3 To support patients in coping with the impact NETs have on their quality of life and collaborate with their care team on treatment decisions, Alira Health and the Carcinoid Cancer Foundation have collaborated since 2015 to build "NET Cancer Health Storylines," a customized version of the Health Storylines™ app that makes it easy for patients to record their symptoms, nutritional concerns, moods, medication and more. The NET Health Storylines app provides patients with resources developed by NET experts. Specific tools include a Stool Diary, NET Nutrition tool, Medication tracker, and additional educational resources. The app is available for download at the NET Cancer Health Storylines website or through the Apple App Store or Google Play. "We are grateful for this support from TerSera to continue to enhance the NET Health Storylines platform to distribute meaningful educational content to NETs patients. The resources available through this platform are important tools in supporting NET patients throughout their journey," said Keith Warner, Chief Executive Officer of the Carcinoid Cancer Foundation. TerSera Therapeutics is the manufacturer of Xermelo (telotristat ethyl), the only oral medication approved for the treatment of carcinoid syndrome diarrhea (CSD), in combination with somatostatin analog (SSA) therapy.4 "Collaborating with CCF and the NET Cancer Health Storylines platform is a fantastic opportunity for us to support patients with Carcinoid Syndrome Diarrhea beyond our existing clinical nurse educator program. We are also looking forward to learning from patients how we can continue to support them better on their journey," said Pamela Gaytan, Executive Director, Clinical Nurse Educators and Patient Advocacy of TerSera Therapeutics. About Carcinoid Syndrome and Carcinoid Syndrome Diarrhea Carcinoid syndrome (CS) is a rare condition which affects approximately 1 out of every 5 patients with neuroendocrine tumors (NETs).5 In CS, patients have NETs that overproduce certain hormones such as serotonin, bradykinin, and histamine.1 One key hormone that is overproduced in CS is serotonin. Elevated serotonin levels in patients with CS can cause carcinoid syndrome diarrhea (CSD) which is characterized by increased motility in the gastrointestinal (GI) tract and reduced absorption of water and nutrients.2 Patients with CSD can experience multiple, urgent, loose and watery stools several times a day. CSD can have a prominent effect on patients' quality of life. Patients with CSD may avoid social activities and have increased fatigue, anxiety, and weight loss.2,3 About Xermelo Xermelo is the first and only approved oral therapy for CSD.4 Xermelo targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells, providing an additional treatment option for patients suffering from CSD. Xermelo is approved in the United States, the European Union, and certain additional countries for the treatment of CSD in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Patients and healthcare professionals with questions about Xermelo should call 1-844-334-4035 or visit . IMPORTANT SAFETY INFORMATION ABOUT XERMELO: Indication Xermelo is a tryptophan hydroxylase inhibitor indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Contraindications: XERMELO is contraindicated in patients with a history of a hypersensitivity reaction to telotristat. Reactions have included angioedema, rash and pruritis. Warnings and Precautions: XERMELO may cause constipation, which can be serious. Serious complications of constipation have been reported during clinical trials and post marketing with individual reports of intestinal perforation, obstruction, and fecaloma. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops. Adverse Reactions: In a clinical trial of patients with carcinoid syndrome diarrhea and 4-12 bowel movements per day, the most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia. In a second clinical trial of patients with carcinoid syndrome diarrhea and less than 4 bowel movements per day, additional adverse reactions of abdominal pain and constipation were reported in ≥5% of patients. Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 and CYP2B6 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. Use in Special Populations: Xermelo is not recommended in patients with moderate and severe hepatic impairment. For more information, please see the full Prescribing Information for Xermelo. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. You can also contact TerSera Therapeutics at 1-844-334-4035 or [email protected]. About TerSera Therapeutics TerSera Therapeutics acquires, develops, and markets specialty pharmaceutical products with a focus on oncology and non-opioid pain. Its mission is to provide products which truly make a difference for patients. For more information about TerSera Therapeutics, please visit . About Carcinoid Cancer Foundation: The Carcinoid Cancer Foundation is the oldest nonprofit carcinoid and neuroendocrine cancer organization in the United States, founded in 1968. The mission of the foundation is to increase awareness and educate the general public and healthcare professionals regarding neuroendocrine tumors (NETs), to support NET cancer patients and their families, and to serve as patient advocates. Visit the CCF website for more information, . About Alira Health Alira Health is a global healthcare firm whose mission is to humanize healthcare and life sciences in partnership with patients. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle, including clinical operations, real-world evidence, and patient-centric technology offerings. Our integrated and multidisciplinary team of over 600 scientists, strategists, economists, clinicians, and biostatisticians collaborate across our North American, European, and Asian offices and advise 80% of the top 50 MedTech companies and 75% of the top 50 Pharma companies. More information may be obtained at . Media Contacts: References: Clement D, Ramage J, Srirajaskanthan R. Update on Pathophysiology, Treatment, and Complications of Carcinoid Syndrome. J Oncol. 2020 Jan 21;2020:8341426. Naraev BG, Halland M, Halperin DM, et al. Management of Diarrhea in Patients With Carcinoid Syndrome. Pancreas. 2019 Sep;48(8):961-972. Anthony L, Ervin C, Lapuerta P, Kulke MH, Kunz P, Bergsland E, Hörsch D, Metz DC, Pasieka J, Pavlakis N, Pavel M, Caplin M, et al. Understanding the Patient Experience with Carcinoid Syndrome: Exit Interviews from a Randomized, Placebo-controlled Study of Telotristat Ethyl. Clin Ther. 2017 Nov;39(11):2158-2168. XERMELO® (telotristat ethyl) Prescribing Information. TerSera Therapeutics LLC. Halperin DM, Shen C, Dasari A, Xu Y, et al. Frequency of carcinoid syndrome at neuroendocrine tumour diagnosis: a population-based study. Lancet Oncol. 2017 Apr;18(4):525-534. Xermelo® is a registered trademark of TerSera Therapeutics LLC or its affiliates. ©2022 TerSera Therapeutics LLC. All rights reserved. SOURCE TerSera Therapeutics LLC

Drug Approval

06 May 2021

·www.globenewswire.com

Lexicon Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Clinical Update

Conference Call and Webcast at 5:00 pm Eastern Time THE WOODLANDS, Texas, May 06, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended March 31, 2021 and provided an update on key milestones. “We continue to enroll patients in our two proof-of-concept Phase 2 clinical studies for LX9211 in neuropathic pain and look forward to results from these studies by the end of the year,” said Lonnel Coats, Lexicon’s president and chief executive officer. “We are also very pleased with the regulatory feedback received from the FDA on sotagliflozin in heart failure and we are moving expeditiously forward with a planned NDA filing in that indication this year.” First Quarter Highlights LX9211 Sotagliflozin 2021 Anticipated Milestones and Events First Quarter 2021 Financial Highlights Revenues: Revenues for the three months ended March 31, 2021 were negligible as compared to $8.0 million for the corresponding period in 2020, primarily due to the absence of product revenues as a result of the sale of XERMELO during the third quarter of 2020. Research and Development (R&D) Expenses: Research and development expenses for the three months ended March 31, 2021 decreased to $12.6 million from $55.2 million for the corresponding period in 2020, primarily due to decreases in external clinical development costs related to sotagliflozin resulting from the completion of clinical studies. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended March 31, 2021 decreased to $8.3 million from $14.7 million for the corresponding period in 2020, primarily due to lower salaries and benefit costs as a result of reductions in personnel in September 2020 and lower marketing expenses. Net Loss: Net loss for the three months ended March 31, 2021 was $21.0 million, or $0.15 per share, as compared to a net loss of $66.6 million, or $0.63 per share, in the corresponding period in 2020. For the three months ended March 31, 2021 and 2020, net income included non-cash, stock-based compensation expense of $2.9 million and $4.4 million, respectively. Cash and Investments: As of March 31, 2021, Lexicon had $141.4 million in cash and investments, as compared to $152.3 million as of December 31, 2020. Conference Call and Webcast Information Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8456671. The live webcast and replay may be accessed by visiting Lexicon’s website at . An archived version of the webcast will be available on the website for 14 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon advanced one of these medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, heart failure, diabetes and metabolism and other indications. For additional information, please visit . Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of LX9211, sotagliflozin and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Lexicon Pharmaceuticals, Inc. Selected Financial Data For Inquiries: Chas SchultzExecutive Director, Corporate Communications and Investor RelationsLexicon Pharmaceuticals(281) 863-3421cschultz@lexpharma.com

Financial Statement

12 Oct 2012

·www.biospace.com

Lexicon Pharmaceuticals, Inc. Initiates Phase 3 Clinical Trial of Telotristat Etiprate in Patients With Carcinoid Syndrome

THE WOODLANDS, Texas, Oct. 12, 2012 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, announced today that it has initiated a registrational, Phase 3 clinical trial of telotristat etiprate, an investigational new drug candidate for the treatment of carcinoid syndrome. Carcinoid syndrome is a chronic condition caused by neuroendocrine tumors that usually originate from the gastrointestinal tract. It is characterized by severe diarrhea and flushing episodes with long-term consequences including malnutrition, heart disease, and death. Carcinoid syndrome has been linked to excess production of serotonin by metastatic tumor cells. Telotristat etiprate is an oral drug candidate designed to treat carcinoid syndrome by reducing serotonin production in patients with metastatic carcinoid tumors. Telotristat etiprate has Fast Track status and Orphan Drug designation from the U.S. Food and Drug Administration, and Orphan designation from the European Medicines Agency. "The registrational, Phase 3 study is designed to evaluate the efficacy and safety of telotristat etiprate in patients with carcinoid syndrome that is refractory to somatostatin therapy," said Pablo Lapuerta M.D., senior vice president and chief medical officer at Lexicon. "We are encouraged by the consistent clinical results obtained to date in two Phase 2 trials that showed telotristat etiprate significantly improved multiple dimensions of carcinoid syndrome with a favorable safety profile." The Phase 3 registrational trial is a 12-week, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telotristat etiprate as a new treatment for carcinoid syndrome that is refractory to current therapy. Two dose levels of telotristat etiprate, 250mg and 500mg three times daily (TID), will be tested along with placebo. The study will include approximately 105 patients with refractory carcinoid syndrome on background somatostatin analog therapy, assigned equally among the 3 treatment groups using a 1:1:1 randomization plan. After the 12-week treatment period, patients will enter a 36 week open-label extension period where all patients will receive telotristat etiprate 500mg TID. About Telotristat Etiprate (LX1032) Telotristat etiprate was discovered and developed at Lexicon to reduce serotonin production by inhibiting tryptophan hydroxylase (TPH), a key enzyme in the synthesis of serotonin. Serotonin's breakdown product, 5-HIAA, is a biomarker used in the diagnosis of the condition. In preclinical studies, telotristat etiprate reduced 5-HIAA and peripheral serotonin in several different species without affecting serotonin levels in the brain. Telotristat etiprate is a member of a new class of oral drugs invented by Lexicon, the serotonin synthesis inhibitors, which are being developed in a spectrum of gastrointestinal indications. Lexicon is also carrying out a Phase 2 trial of telotristat etiprate in mild to moderate ulcerative colitis. About Carcinoid Syndrome Carcinoid syndrome is a chronic condition caused by metastatic neuroendocrine tumors that usually originate from the gastrointestinal tract. Patients with carcinoid syndrome currently have limited therapeutic options, and the standard of care includes chronic therapy with somatostatin analogs, which are delivered by injection. With current therapy, carcinoid syndrome symptoms return over time in most patients, hence the need for new agents. About Lexicon Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease. Lexicon currently has four drug programs in mid-stage development for diabetes, carcinoid syndrome, irritable bowel syndrome and rheumatoid arthritis, all of which were discovered by Lexicon's research team. Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets. Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs. For additional information about Lexicon and its programs, please visit . Safe Harbor Statement This press release contains "forward-looking" statements, including statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct preclinical and clinical development of its potential drug candidates, advance additional candidates into preclinical and clinical development, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2011, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. SOURCE Lexicon Pharmaceuticals, Inc.

CollaborateOrphan DrugFast Track

100 Deals associated with Telotristat Etiprate

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KEGG	Wiki	ATC	Drug Bank
D09975	Telotristat Etiprate	A16A	DB12095

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Malignant Carcinoid Syndrome	US	TerSera Therapeutics LLCStartup	28 Feb 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carcinoid Heart Disease	Phase 3	-	Ipsen SA	01 Apr 2020
Advanced Pancreatic Adenocarcinoma	Phase 2	US	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	US	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Pancreatic adenocarcinoma metastatic	Phase 2	US	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Colitis, Ulcerative	Phase 2	US	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Colitis, Ulcerative	Phase 2	LT	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Colitis, Ulcerative	Phase 2	PL	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Colitis, Ulcerative	Phase 2	SK	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Liver Diseases	Phase 1	US	Lexicon Pharmaceuticals, Inc.	28 Nov 2017
Hepatic Insufficiency	Phase 1	MD	Ipsen SA	01 Feb 2016

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03790111 (CTgov)	Phase 2	Advanced Bile Duct Carcinoma	53	Xermelo	onbnlqtgux(yqfnzcepjs) = gdylgorwvo dmceuqpwef (wyfisitghg, zvzwapymgl - jsavnkttot) View more	-	19 Apr 2023
ASCO2022	Not Applicable	Apudoma	67	PRRT alone	gtmqfrempw(xihuupunyq) = karzgujtit lhtthulydd (necdmbjset ) View more	-	02 Jun 2022
				PRRT with telotristatPRRT with telotristat	gtmqfrempw(xihuupunyq) = glmpkjehlg lhtthulydd (necdmbjset ) View more
TELESTAR and TELECAST (Pubmed \| Clin Ther)	Phase 3	Malignant Carcinoid Syndrome	-	Telotristat Ethyl	wfdwgavhhd(exynfesdql) = wzqcilggxi ouyrpaurcw (ojlflghfcw ) View more	-	01 Oct 2021
TELEACE (ASCO_GI2021)	Not Applicable	Well Differentiated Pancreatic Endocrine Tumor	-	Telotristat ethyl	gkkijglfjw(ptozshukfy) = hhpvhkduzz lyvryxudpm (pqpvoknvqs )	Positive	22 Jan 2021
NCT02026063 (CTgov)	Phase 3	Malignant Carcinoid Syndrome	124	Telotristat Etiprate (Telotristat Etiprate 250 mg)	phmxegirqp(gsowzedlzs) = ydftwrmzwv yxdyhzsxrr (xsarvyhkmx, dkdniicqxq - iaeopefjew) View more	-	17 Sep 2019
				Etiprate+Telotristat (Telotristat Etiprate 500 mg)	phmxegirqp(gsowzedlzs) = nlnkqebjnb yxdyhzsxrr (xsarvyhkmx, ivzkzzbbef - jtffqvladt) View more
NCT03442725 (CTgov)	Phase 1	Renal Insufficiency	16	telotristat etiprate (Healthy Subjects (Control Group))	hvhvrtwcyi(kekyygxeap): Geometric Mean Ratio = 1.297 (90% CI, 0.600 - 2.805); Geometric Mean Ratio = 1.423 (90% CI, 0.901 - 2.247) View more	-	13 Sep 2019
				telotristat etiprate (Severe Renal Impairment (Test Group))
NCT00853047 (CTgov)	Phase 2	Malignant Carcinoid Syndrome	23	Placebo+Octreotide LAR Depot (Placebo Core Phase)	awsuldlzza(cqpkfvkxfz) = byjhlqqoxt xsuhcukgfl (jqrvdlbahs, lzrikebkdt - gwolhmwgiw) View more	-	26 Dec 2018
				Octreotide LAR Depot+Telotristat etiprate (Telotristat Etiprate 150 mg Core Phase)	awsuldlzza(cqpkfvkxfz) = vbewmbnkns xsuhcukgfl (jqrvdlbahs, txvsuqhecl - mobjkjfxer) View more
NCT01677910 (TELESTAR, Pubmed \| Clin Ther)	Phase 3	Malignant Carcinoid Syndrome	135	Placebo	gvcxaouarz(zmkxmifzkm) = ygpncwbfol jnzrsrjexz (rbefctsteg ) View more	-	01 Jun 2018
				Telotristat ethyl 250 mg	gvcxaouarz(zmkxmifzkm) = dspnjvuhof jnzrsrjexz (rbefctsteg ) View more
NCT01104415 (CTgov)	Phase 2	Malignant Carcinoid Syndrome	15	Telotristat (Telotristat Etiprate- Core Phase)	ppntraisxk(pyqeqiwwds) = bnqjiudare unxyjpxewm (fpwmlohmgw, wbgxlzjtlf - nbkkoyjsse) View more	-	06 Apr 2018
				Telotristat (Telotristat Etiprate- Extension Period)	ppntraisxk(kpzgblngfr) = qnuiboldjk vlgiphhhzp (hlfgkkrxib, vlgriogzlo - nggizgwuro) View more
NCT02063659 (CTgov)	Phase 3	Malignant Carcinoid Syndrome	76	placebo (Placebo)	siycomwvsw(umuxfuxbmd) = pmpjgmjdme ylpxikqkms (ptlwmwvtxj, xfdseinttr - ozqeadrtpg) View more	-	25 Sep 2017
				placebo+Telotristat etiprate (250 mg Telotristat Etiprate)	siycomwvsw(umuxfuxbmd) = zbtfsmrlmk ylpxikqkms (ptlwmwvtxj, ovkzzlsgnl - jnlzlcikdy) View more

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Core Patent

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

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Regulation

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Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis