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

NCT04543955

/ TerminatedPhase 2IIT

Study of Telotristat (Xermelo) in Combination With Luetetium Lu177 Dotatate (Lutathera) in Well-Differentiated Neuroendocrine Tumors

This trial will test the hypothesis that Telotristat treatment increases the antitumor efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).

Start Date13 Sep 2021

Sponsor / Collaborator

University of Kentucky

[+1]

NCT04810091

/ Active, not 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

100 Clinical Results associated with Telotristat Etiprate

100 Translational Medicine associated with Telotristat Etiprate

100 Patents (Medical) associated with Telotristat Etiprate

125

Literatures (Medical) associated with Telotristat Etiprate

01 May 2025·ADVANCES IN THERAPY

Burden of Comorbidities and Concomitant Medications and Their Associated Costs in Patients with Gastroenteropancreatic or Lung Neuroendocrine Tumors: Analysis of US Administrative Data

Article

Author: Starr, Jason ; Pommie, Christelle ; Houchard, Aude ; Ribeiro-Oliveira, Antonio ; Liu, Yutong ; Naga, Sai Sriteja Boppudi ; Chan, Jennifer A ; Vandamme, Timon ; Dennen, Syvart ; Zhao, Yajin

INTRODUCTION:

This study investigated the burden of comorbidities and concomitant non-cancer medications and their cost in patients with neuroendocrine tumors (NETs).

METHODS:

Adults with gastroenteropancreatic (GEP)-NETs and lung-NETs, with or without carcinoid syndrome (CS), who initiated first-line NET treatment (index date) with a somatostatin analog or telotristat and had ≥ 1 inpatient or ≥ 2 distinct outpatient claims (study period January 1, 2016-December 31, 2022) were identified from the US MarketScan database and matched (age, sex, insurance type) with up to four adults without cancer (reference group). At 0-90 and 91-180 days post-index, medication counts (generalized linear model, GLM), medication frequency distributions (chi-squared test), and medication costs in USD (two-part model: logit model and GLM for the first and second parts, respectively) were assessed. Frequencies of comorbidities of interest (≥ 1 diagnosis claim) in the 6 months post-index were calculated.

RESULTS:

A total of 662 patients with GEP-NETs (279 with CS) and 84 with lung-NETs (30 with CS) were included. Irrespective of CS status, mean medication counts in the 0-90 and 91-180 days post-index was 1.5-1.8 times higher for GEP-NETs (p < 0.001) and 1.6-1.9 times higher for lung-NETs (p < 0.005) than reference groups. Medications most frequently prescribed for both NET groups were oral cardiovascular, central nervous system, and gastrointestinal agents. The most common comorbidities of interest in patients with NETs (vs reference groups) were hypertension (GEP-NETs: 68.7% vs 55.0%; lung-NETs: 73.8% vs 58.3%) and type 2 diabetes (GEP-NETs: 35.5% vs 24.1%; lung-NETs: 50.0% vs 28.3%). Excluding anticancer medications, mean per-patient-per-month medication costs (vs reference groups) were $276-811 (vs $176-349) and $390-647 (vs $210-$302) for 0-90 days and 91-180 days post-index, respectively.

CONCLUSION:

Compared with people without cancer, patients with NETs had a higher prevalence of comorbidities and concomitant medication use, which was associated with a greater economic burden.

01 Jan 2025·ECOTOXICOLOGY AND ENVIRONMENTAL SAFETY

Inhaling arsenic aggravates airway hyperreactivity by upregulating PNEC-sourced 5-HT in OVA-induced allergic asthma

Article

Author: Tan, Zhu-Xia ; Wang, Yan ; Lu, Xue ; Peng, Kun ; Li, Ze-Yan ; Li, Zhao ; Yang, Qian-Qun ; Xu, De-Xiang ; Zhu, Yan-Yan ; Yao, Ya-Xin

Increasing epidemiological evidence has proved that early-life exposure to inorganic arsenic (As) elevates the risks of childhood asthma. The present research aimed to explore susceptibility of respiratory As exposure to allergic asthma in a mouse model. BALB/c mice on postnatal day (PND) 28 were exposed to ddH₂O or NaAsO₂ aerosol for 4 hours daily over 5 consecutive weeks via respiratory tract. Mice were sensitized by intraperitoneal injection of ovalbumin (OVA) combined with Alum Adjuvant on PND42 and PND56. Subsequently, mice were challenged with ddH₂O or 1 %OVA through a nebulizer for 3 days starting from PND63. In As-exposed mice, OVA-sensitized goblet cell hyperplasia and airway mucosal secretion did not worsen. OVA-induced inflammatory cell infiltration and upregulation of Th2 cytokines, including IL-4, IL-5, and IL-13, were not aggravated in As-exposed mice. Interestingly, airway hyperreactivity was intensified in As-exposed asthmatic mice. Mechanistically, OVA-induced elevation of 5-hydroxytryptamine (5-HT), probably secreted by pulmonary neuroendocrine cells (PNECs), was exacerbated in As-exposed mice. OVA-induced upregulation of tryptophan hydroxylase (TPH)1 and TPH2, two 5-HT synthases, was aggravated in As-exposed mouse lungs. LX1032, a specific TPH inhibitor, suppressed As-induced elevation of pulmonary 5-HT content in asthmatic mice. Moreover, LX1032 alleviated As-evoked airway hyperreactivity in asthmatic mice. These results suggest that respiratory As exposure elevates airway hyperreactivity partially through upregulating PNEC-sourced 5-HT in OVA-induced allergic asthma, which provides significant insight about the hazards of environmental As exposure.

01 Dec 2024·Molecular Catalysis

Gene hunting and semi-rational design of carbonyl reductase from Kosakonia radicincitans for highly efficient synthesis of the key chiral intermediate of Telotristat ethyl

Author: Qian, Feng ; Wang, Yao-Wu ; Zhang, Hai-Min ; Wang, Pu ; Liu, Han-Yu ; Ning, Pan

Carbonyl reductase exhibits significant potential in the asym. production of chiral alcs. (αR)-4-Chloro-2-(3-methyl-1H-pyrazol-1-yl)-α-(trifluoromethyl)benzenemethanol ((R)-CMPPFO) is a critical precursor for the synthesis of Telotristat Et, an oral drug for the treatment of diarrhea in carcinoid syndrome.Herein, a novel carbonyl reductase KrSDR5 from Kosakonia radicincitans was obtained using gene hunting strategy, capable of asym. reducing the precursor ketone 1-[4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl]-2,2,2-trifluoroethanone (CMPPFA) to (R)-CMPPFO with strict R-stereoselectivity (>99.9% ee).Further, semi-rational design was adopted to acquire a pos. mutant KrSDR5_{T91V/V141M/I159V}, with assistance from a comparative anal. of enzyme-substrate binding mode in mol. dynamics (MD) simulations.This variant displayed a 12.4-fold increase in k_cat/K_m towards CMPPFA compared to the wild-type (WT) KrSDR5.Insights were gained on the high enantioselectivity and the enhancement of enzyme catalytic activity of the mutant through MD simulations.Using the whole-cells of KrSDR5_{T91V/V141M/I159V} as biocatalyst, the asym. synthesis of (R)-CMPPFO was achieved within 20 h at 500 mM CMPPFA concentration, resulting in a 95.0% yield with >99.9% ee, and a highest space-time yield (STY) of 165.7 g·L^-1·d^-1 compared with previous reports.This study provides a robust biocatalyst for highly efficient production of the key precursor (R)-CMPPFO for Telotristat Et, highlighting its potential in the biosynthesis of pharmaceutical intermediates.

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

31 Jan 2017

·www.biospace.com

6 Biopharma Companies Face Catalysts in February

January 31, 2017 By Mark Terry , BioSpace.com Breaking News Staff If January has been a little bit slow in terms of catalysts in biopharma, February is going to change that. Bret Jensen, writing for Seeking Alpha, discusses a number of PDUFA dates and key clinical trial data releases coming in the month of February. 1. Amgen Amgen ’s Parsabiv has a PDUFA date of February 9. The drug was approved in Europe in November 2016 for the treatment of secondary hyperparathyroidism in adults on hemodialysis. It is up for a decision by the U.S. Food and Drug Administration (FDA) . Amgen is currently trading for $155.74. 2. Valeant Pharmaceuticals The company’s brodalumab for psoriasis is awaiting an FDA decision on February 16. If approved, Valeant Pharmaceuticals would likely launch in the second quarter. The market is projected to be $10 billion. Jensen writes, “The beaten down ‘pariah’ of the drug industry could use any good news at the moment. Valeant is currently trading for $13.60. 3. Amphastar Rancho Cucamonga, Calif.-based Amphastar has a February 19 PDUFA date for an intranasal version of naxolone for opioid overdose. Jensen writes, “I know little of the company but another SeekingAlpha contributor has a bearish view on the company right now. Also after getting burned by the recent FDA labeling decision on the intranasal version of ARYMO ER from Egalet , I would be somewhat leery of the stock and the upcoming FDA decision.” On December 27, 2016, the FDA shot down the company’s New Drug Application for Primatene Mist, indicating that it couldn’t be approved in its present form. Amphastar is currently trading for $15.49. 4. Lexicon Pharmaceuticals Lexicon Pharmaceuticals has a February 28 PDUFA date for Telotristat for carcinoid syndrome. Jensen writes, “Based on trial results, I view the approval as likely and recently highlighted why I like the maker of this compound, Lexicon Pharmaceuticals as an investment right now.” Lexicon is currently trading for $13.93. 5. Amicus Therapeutics Amicus Therapeutics is expected to release additional data from its Phase I/II clinical trial for ATB200 in Pompe Disease at the 13th Annual WORLD Symposium February 13-17. It provided preliminary data in December that was positive. The company is also awaiting a decision in late March in Europe for Galafold for Fabry disease. Jensen writes, “I think Amicus is undervalued just based on its approved compound Galafold for the treatment of Fabry Disease outside the United States.” Amicus is currently trading for $5.33. 6. Axovant Sciences Axovant Sciences is expected to announce Phase II data from its trial of Nelotanserin for visual hallucinations associated with Lewy body dementia. In early December, Axovant announced positive data from a Phase IIb trial of intepirdine (RVT-101), combined with standard of care donepezil, in mild-to-moderate Alzheimer’s disease. Jensen writes, “It is a busy year for the company’s pipeline development. The key catalyst will be for Phase III data for its compound Intepirdine aimed at Alzheimer’s Disease. This is due out in the third quarter and most likely to cause at least a 50 percent move in either direction when released depending on the results.” Axovant is currently trading for $11.98.

Clinical ResultDrug ApprovalPhase 2Phase 3

100 Deals associated with Telotristat Etiprate

External Link

KEGG	Wiki	ATC	Drug Bank
D09974 D09975	Telotristat Etiprate	A16A	DB12095

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Malignant Carcinoid Syndrome	United States	TerSera Therapeutics LLC	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
Apudoma	Phase 2	United States	TerSera Therapeutics LLC	13 Sep 2021
Neuroendocrine Tumors	Phase 2	United States	TerSera Therapeutics LLC	13 Sep 2021
Advanced Pancreatic Adenocarcinoma	Phase 2	United States	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Locally Advanced Pancreatic Adenocarcinoma	Phase 2	United States	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Pancreatic adenocarcinoma metastatic	Phase 2	United States	Lexicon Pharmaceuticals, Inc.	17 Apr 2019
Advanced biliary tract cancer	Phase 2	United States	TerSera Therapeutics LLC	13 Mar 2019
Colitis, Ulcerative	Phase 2	United States	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Colitis, Ulcerative	Phase 2	Lithuania	Lexicon Pharmaceuticals, Inc.	30 Jan 2012
Colitis, Ulcerative	Phase 2	Poland	Lexicon Pharmaceuticals, Inc.	30 Jan 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03453489 (CTgov)	Phase 2	Malignant Carcinoid Syndrome	4	Positron Emission Tomography+Telotristat Etiprate	kbbtxrhyop = gcmkceunfq osmwfoifbx (dacnwltpfc, aczioitbgc - obxiqncfvk) View more	-	10 Apr 2025
NCT04543955 (CTgov)	Phase 2	Neuroendocrine Tumors \| Apudoma	1	Telotristat (Low-Dose) (Arm 1: Low-Dose Telotristat)	qmzjbhhbst(gopyuofuxl) = coohsmctkt yryrcbzoqy (ovfsbtswgq, ipkyszfjcb - eqdryvqwcc) View more	-	27 Jun 2023
				Telotristat (High-Dose) (Arm 2: High-Dose Telotristat)	qmzjbhhbst(gopyuofuxl) = mgknnhxuyf yryrcbzoqy (ovfsbtswgq, vuomudvdxh - ttkzqzbuyk) View more
NCT03790111 (TELE-ABC, CTgov)	Phase 2	Advanced biliary tract cancer	53	Xermelo	vjqzmjelgq = iricoofmco lngodhvzpc (whlbvnfpoy, bszxiuegyt - bcdetgzbno) View more	-	19 Apr 2023
ASCO2022	Not Applicable	Apudoma	67	PRRT alone	xgftluaqfo(bpehijgkgf) = mqffvlvmsc ysvziirdfw (rakryqdrzq ) View more	-	02 Jun 2022
				PRRT with telotristat	xgftluaqfo(bpehijgkgf) = pvsezbyjdh ysvziirdfw (rakryqdrzq ) View more
NCT01677910 \| NCT02063659 (TELECAST, Pubmed \| Clin Ther)	Phase 3	Malignant Carcinoid Syndrome	-	Telotristat Ethyl	jhiuajlnua(dnthkpvpan) = lohpuqwzaw isfdogimal (apviuvatrk ) View more	-	01 Oct 2021
TELEACE (ASCO_GI2021)	Not Applicable	Well Differentiated Pancreatic Endocrine Tumor	-	Telotristat ethyl	virecjyfzn(augmsbqtfi) = xvgohiqmef kqozvddfjb (pcufhtpnpa )	Positive	22 Jan 2021
NCT02026063 (TELEPATH, CTgov)	Phase 3	Malignant Carcinoid Syndrome	124	Telotristat Etiprate (Telotristat Etiprate 250 mg)	tuaszpzxds = oeynmorvjx bizzkjtxit (gscvhpkahj, xorniifqrz - weqwzaovyg) View more	-	17 Sep 2019
				Etiprate+Telotristat (Telotristat Etiprate 500 mg)	tuaszpzxds = mcgkvcndug bizzkjtxit (gscvhpkahj, upoebgopvj - ofyfrixyof) View more
NCT03442725 (CTgov)	Phase 1	Renal Insufficiency	16	telotristat etiprate (Healthy Subjects (Control Group))	claakafzoy(lsdrasmluk) = xnslbwudhd cdhsjxnjin (kbrosuefhg, 98.9) View more	-	13 Sep 2019
				telotristat etiprate (Severe Renal Impairment (Test Group))	claakafzoy(lsdrasmluk) = idfnzgfyov cdhsjxnjin (kbrosuefhg, 116) View more
NCT00853047 (CTgov)	Phase 2	Malignant Carcinoid Syndrome	23	Placebo+Octreotide LAR Depot (Placebo Core Phase)	gbduavpilk = lvkdwbjoip yuxoikdcgx (sfckbymcxc, dqpdnbhmkj - vtjkmnyexo) View more	-	26 Dec 2018
				Octreotide LAR Depot+Telotristat etiprate (Telotristat Etiprate 150 mg Core Phase)	gbduavpilk = ygttjolvgi yuxoikdcgx (sfckbymcxc, atxowdtkjw - wqsmknqcon) View more
NCT01677910 (TELESTAR, Pubmed \| Clin Ther)	Phase 3	Malignant Carcinoid Syndrome	135	Placebo	ovfdrvjdaw(lrmyzbavgk) = pzotklhvnp hbfrhlptpx (qluufydnwx ) View more	-	01 Jun 2018
				Telotristat ethyl 250 mg	ovfdrvjdaw(lrmyzbavgk) = quspzrcbhm hbfrhlptpx (qluufydnwx ) View more

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