Xermelo

(Telotristat Etiprate)

Small molecule

TTerSera Therapeutics LLC

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Clinical

Trials by Indication[1]

Carcinoid Syndrome5 trials

Telotristat Etiprate for Carcinoid Syndrome Therapy

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02063659·76 enrolled

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome Not Managed by Stable-Dose Octreotide Therapy

Completed·LLexicon Pharmaceuticals·Phase 2·NCT00853047·23 enrolled

TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)

Completed·LLexicon Pharmaceuticals·Phase 3·NCT01677910·135 enrolled

Show 2 more trials

Telotristat Etiprate - Expanded Treatment for Patients With Carcinoid Syndrome Symptoms

Completed·LLexicon Pharmaceuticals·Phase 3·NCT02026063·124 enrolled

Study of Telotristat Etiprate (LX1606) in Participants With Symptomatic Carcinoid Syndrome

Completed·LLexicon Pharmaceuticals·Phase 2·NCT01104415·15 enrolled

Interaction3 trials

Phase 1, Open-label, Drug-drug Interaction Study With Octreotide Acetate Injection and Telotristat Etiprate in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02195635·24 enrolled

A Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Midazolam in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02147808·24 enrolled

An Open-Label Drug-Drug Interaction Study of Telotristat Etiprate and Fexofenadine in Healthy Subjects

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02157558·24 enrolled

Renal Impairment1 trial

Study to Compare a Dose of Telotristat Etiprate in Subjects With Renal Impairment With Matched Subjects With Normal Renal Function

Completed· Ipsen logo

Ipsen·Phase 1·NCT03442725·16 enrolled

Neuroendocrine Neoplasm1 trial

AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm

Completed·BBarbara Ann Karmanos Cancer Institute·Phase 2·NCT03453489·4 enrolled

Hepatic Insufficiency1 trial

Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects

Completed· Ipsen logo

Ipsen·Phase 1·NCT02683577·24 enrolled

2 more indications

Ulcerative Colitis1 trial

A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

Completed·LLexicon Pharmaceuticals·Phase 2·NCT01456052·59 enrolled

Unspecified2 trials

A Thorough QT Study of Telotristat Etiprate

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02155205·48 enrolled

An Open-Label Food Effect Study of Telotristat Etiprate

Completed·LLexicon Pharmaceuticals·Phase 1·NCT02157584·22 enrolled

Regulatory

FDA Approval Timeline[3]

Feb 28, 2017

XERMELO

NDA NDA208794

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Telotristat Etiprate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Telotristat Etiprate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208794). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Xermelo. U.S. Food & Drug Administration.
[5]
SEC EDGAR — TerSera Therapeutics LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: TTerSera Therapeutics LLC

Patent Landscape[4]

Patent Cliff

Dec 11, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7968559Dec 11, 2027

7553840Dec 11, 2027

8653094Dec 19, 2028

8193204Feb 27, 2031

7709493Feb 28, 2031