Mytesi

(crofelemer)

ApprovedSmall molecule

NNapo Pharmaceuticals, Inc.

Mytesi is one of 11 small molecule programs targeting Diarrhea. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Short Bowel SyndromeActive, not recruiting

Short Bowel SyndromePhase 1

Active, not recruiting

Competition

Competitive Landscape

13 competitors in Short Bowel Syndrome

#DrugCompanyPhaseTrials

Eliquis

Bristol-Myers Squibb

Approved

1 2

Victoza

Novo Nordisk

Approved

—3

Mytesi

NNapo Pharmaceuticals, Inc.

Approved

1 4

Glepaglutide

Zealand Pharma

Phase 3

5 5

Apraglutide

VVectivBio AG

Phase 3

2 6

PJ009

CChongqing Peg-Bio Biopharm Co., Ltd.

Phase 3

1 7

Celexa

AbbVie

Preclinical

1 8

Genotropin

Glutamine

1 10

FT1

CChongqing Peg-Bio Biopharm Co., Ltd.

Phase 2

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Short Bowel Syndrome

NCT06326645

Clinical

Trials by Indication[1]

Diarrhea6 trials

Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea

Completed·NNapo Pharmaceuticals, Inc.·Phase 4·NCT04192487·17 enrolled

Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea

Completed·BBausch Health Americas, Inc.·Phase 3·NCT01374490·250 enrolled

Prophylaxis of Diarrhea in Adult Cancer Patients Receiving Targeted Cancer Therapy

Completed·NNapo Pharmaceuticals, Inc.·Phase 3·NCT04538625·287 enrolled

Show 3 more trials

Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea

Completed·BBausch Health Americas, Inc.·Phase 3·NCT00547898·374 enrolled

Crofelemer for Functional Diarrhea

Terminated·—·Phase 4·NCT04486326·17 enrolled

Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients

Completed·TThe University of Texas Health Science Center, Houston·Phase 4·NCT03898856·93 enrolled

Breast Cancer2 trials

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

Completed·UUniversity of California, San Francisco·Phase 2·NCT03094052·11 enrolled

Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients

Completed·SSandra Swain·Phase 2·NCT02910219·53 enrolled

Immunodeficiency2 trials

Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel With Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects With Acquired Immunodeficiency Syndrome (AIDS)

Completed·SShaman Pharmaceuticals·N/A·NCT00002186·400 enrolled

A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Orally Administered SP-303 for the Treatment of Diarrhea in Acquired Immunodeficiency Syndrome (AIDS) Patients

Completed·SShaman Pharmaceuticals·Phase 3·NCT00002408·300 enrolled

Irritable Bowel Syndrome2 trials

A Study of Crofelemer to Treat Diarrhea Irritable Bowel Syndrome

Completed·BBausch Health Americas, Inc.·Phase 2·NCT00101725·245 enrolled

Diarrhea Predominant Irritable Bowel Syndrome in Females

Completed·BBausch Health Americas, Inc.·Phase 2·NCT00461526·240 enrolled

Herpes Simplex Virus1 trial

SP-303T Applied to the Skin of Patients With Herpes Simplex Virus (HSV) Infection and AIDS Who Have Not Had Success With Acyclovir

Completed·SShaman Pharmaceuticals·N/A·NCT00002310

1 more indication

Short Bowel Syndrome1 trial

Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome

Active, not recruiting·LLindsey Russell, MD·Phase 1·NCT06326645·6 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 31, 2012

MYTESI

NDA NDA202292

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for crofelemer. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — crofelemer compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for crofelemer. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202292). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Mytesi. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Napo Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: NNapo Pharmaceuticals, Inc.

Patent Landscape[5]

Patent Cliff

Oct 31, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9585868Oct 31, 2031

8962680Oct 31, 2031

Mytesi

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Diarrhea6 trials

Breast Cancer2 trials

Immunodeficiency2 trials

Irritable Bowel Syndrome2 trials

Herpes Simplex Virus1 trial

Short Bowel Syndrome1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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