Hepatic Impairment

Gastroenterology
81
Pipeline Programs
30
Companies
50
Clinical Trials
5 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
79
0
0
0
0
2
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Small Molecule
1387%
Peptide
213%
+ 64 programs with unclassified modality

On Market (2)

Approved therapies currently available

Takeda
GATTEX KITApproved
teduglutide
Takeda
GLP-2 Analog [EPC]subcutaneous2012
Novartis
VIJOICEApproved
alpelisib
Novartis
oral2024

Competitive Landscape

39 companies ranked by most advanced pipeline stage

Novartis
NovartisBASEL, Switzerland
12 programs
12
1
ABL001Phase 11 trial
AGO178Phase 11 trial
VIJOICE(Alpelisib)Phase 1Small Molecule1 trial
BAF312Phase 11 trial
FIA586Phase 11 trial
+7 more programs
Active Trials
NCT02857868Completed32Est. Jul 2017
NCT01531309Completed32Est. Sep 2011
NCT02624557Completed23Est. Oct 2017
+12 more trials
Takeda
TakedaTOKYO, Japan
3 programs
3
1
FazirsiranPhase 11 trial
TAK-279Phase 11 trial
GATTEX KIT(Teduglutide)Phase 1Peptide5 trials
Active Trials
NCT05891158Completed34Est. Sep 2025
NCT05976321Completed27Est. Apr 2024
NCT06973304Recruiting13Est. Jul 2027
+4 more trials
AstraZeneca
AstraZenecaCAMBRIDGE, United Kingdom
5 programs
5
AZD2693Phase 11 trial
AZD5004Phase 11 trial
CamizestrantPhase 11 trial
LY3314814Phase 1
MitiperstatPhase 1Small Molecule1 trial
Active Trials
NCT05919069Completed35Est. Sep 2024
NCT06813781Completed33Est. Oct 2025
NCT05790304Completed22Est. Feb 2024
+1 more trials
Pfizer
PfizerNEW YORK, NY
5 programs
5
GBT440Phase 11 trial
PF-04965842Phase 11 trial
PF-05221304Phase 11 trial
PF-06865571 100 mgPhase 11 trial
PF-07321332Phase 11 trial
Active Trials
NCT03114540Completed29Est. Mar 2018
NCT03626415Completed24Est. Apr 2019
NCT03309202Completed24Est. Jul 2018
+2 more trials
DS
4 programs
4
DS-3201bPhase 11 trial
QuizartinibPhase 1Small Molecule1 trial
QuizartinibPhase 1Small Molecule1 trial
TivantinibPhase 1Small Molecule1 trial
Active Trials
NCT04276662Completed28Est. Feb 2021
NCT06740799Recruiting12Est. Mar 2026
NCT04473664Completed12Est. Jul 2021
+1 more trials
E
4 programs
4
LemborexantPhase 11 trial
LenvatinibPhase 1Small Molecule1 trial
LorcaserinPhase 11 trial
TasurgratinibPhase 1Small Molecule1 trial
Active Trials
NCT03440424Completed24Est. Apr 2018
NCT02421042Completed14Est. Jul 2012
NCT00828932Completed24Est. Dec 2008
+1 more trials
Astellas
AstellasChina - Shenyang
3 programs
3
ASP2215Phase 11 trial
BocidelparPhase 12 trials
fezolinetantPhase 15 trials
Active Trials
NCT02571816Completed24Est. Mar 2016
NCT05117294Completed13Est. Nov 2022
NCT04942964Completed25Est. Jan 2022
+5 more trials
Biogen
3 programs
3
BG9928Phase 11 trial
Bardoxolone MethylPhase 11 trial
Omaveloxolone 50 mg capsulesPhase 11 trial
Active Trials
NCT00858156Completed23Est. Aug 2009
NCT01563562Completed34Est. Nov 2012
NCT03902002Completed48Est. Jan 2020
Ipsen
IpsenChina - Tianjin
3 programs
3
PalovarotenePhase 11 trial
TazemetostatPhase 1Small Molecule1 trial
telotristat etipratePhase 11 trial
Active Trials
NCT06908954Completed31Est. Feb 2026
NCT04241835Recruiting24Est. Apr 2026
NCT02683577Completed24Est. Jul 2016
Bristol Myers Squibb
2 programs
2
BMS-986141Phase 11 trial
RepotrectinibPhase 1Small Molecule3 trials
Active Trials
NCT02985632Withdrawn0Est. Jul 2017
NCT05926232Available
NCT07223671Recruiting32Est. Mar 2026
+1 more trials
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
2
CMX001Phase 11 trial
SativexPhase 11 trial
Active Trials
NCT05391724Completed25Est. Sep 2011
NCT01887301Completed32Est. May 2014
Novo Nordisk
2 programs
2
CagrilintidePhase 1Peptide1 trial
NNC0194-0499Phase 11 trial
Active Trials
NCT05564104Completed32Est. Dec 2024
NCT05917938Completed33Est. Dec 2024
Corcept Therapeutics
Corcept TherapeuticsCA - Redwood City
2 programs
2
DazucorilantPhase 11 trial
RelacorilantPhase 11 trial
Active Trials
NCT06928779Completed19Est. Dec 2024
NCT06094725Completed30Est. Dec 2020
H
HutchmedChina - Hong Kong
2 programs
2
FruquintinibPhase 1Small Molecule1 trial
SurufatinibPhase 1Small Molecule1 trial
Active Trials
NCT05216367Completed16Est. Oct 2022
NCT04755075Completed16Est. Oct 2021
Kyowa Hakko Kirin
Kyowa Hakko KirinCA - La Jolla
2 programs
2
IstradefyllinePhase 11 trial
KW-6356Phase 11 trial
Active Trials
NCT02256033Completed20Est. Dec 2014
NCT04190654Completed26Est. Mar 2020
M&
Merck & Co.RAHWAY, NJ
2 programs
2
M2951Phase 11 trial
MK-8527Phase 11 trial
Active Trials
NCT04546789Completed24Est. May 2021
NCT07025551Completed18Est. Feb 2026
UP
1 program
1
20 mg HC-ERPhase 11 trial
Active Trials
NCT02242734Completed30Est. May 2011
Alkermes
1 program
1
ALKS 5461Phase 11 trial
Active Trials
NCT02452801CompletedEst. Dec 2015
Insmed
InsmedBRIDGEWATER, NJ
1 program
1
BrensocatibPhase 11 trial
Active Trials
NCT05517525Completed30Est. Jun 2023
AbbVie
AbbVieNORTH CHICAGO, IL
1 program
1
CedirogantPhase 11 trial
Active Trials
NCT05376839Terminated6Est. Nov 2022
SK Life Science
SK Life ScienceNJ - Paramus
1 program
1
CenobamatePhase 11 trial
Active Trials
NCT04791553CompletedEst. Aug 2023
Chipscreen Biosciences
Chipscreen BiosciencesChina - Shenzhen
1 program
1
ChiglitazarPhase 11 trial
Active Trials
NCT05515445CompletedEst. Aug 2023
PTC Therapeutics
1 program
1
DeflazacortPhase 11 trial
Active Trials
NCT02286609Completed16Est. Feb 2015
Alumis
AlumisSOUTH SAN FRANCISCO, CA
1 program
1
ESK-001Phase 11 trial
Active Trials
NCT06952634Recruiting48Est. Dec 2025
Stemline Therapeutics
1 program
1
Elacestrant dihydrochloridePhase 11 trial
Active Trials
NCT06126575Completed16Est. Nov 2024
BP
1
FosmanogepixPhase 11 trial
Active Trials
NCT05582187CompletedEst. Oct 2025
Teva
TevaIsrael - Petach Tikva
1 program
1
Hydrocodone bitartrate extended-release tabletPhase 11 trial
Active Trials
NCT01319279Completed16Est. Aug 2011
Sanofi
SanofiPARIS, France
1 program
1
KD025Phase 11 trial
Active Trials
NCT04166942Completed35Est. Jun 2022
Madrigal Pharmaceuticals
Madrigal PharmaceuticalsWEST CONSHOHOCKEN, PA
1 program
1
MGL-3196Phase 11 trial
Active Trials
NCT04643795Completed87Est. Aug 2021
NewAmsterdam Pharma
NewAmsterdam PharmaNARRDEN, Netherlands
1 program
1
ObicetrapibPhase 11 trial
Active Trials
NCT06048302CompletedEst. Mar 2024

+9 more companies

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide
TakedaTeduglutide

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 1,419 patients across 50 trials

A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome

Start: Jun 2025Est. completion: Jul 202713 patients
Phase 3Recruiting

A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older

Start: Jan 2022Est. completion: Sep 20233 patients
Phase 3Completed

Safety, Efficacy and Pharmacokinetic Study of Teduglutide in Infants 4 to 12 Months of Age With Short Bowel Syndrome

Start: Aug 2018Est. completion: Sep 202010 patients
Phase 3Completed

An Extension Study of Teduglutide in Japanese Participants With Short Bowel Syndrome Who Completed 24 Weeks of Treatment in SHP633-306 or TED-C14-004

Start: Jul 2018Est. completion: Jan 202211 patients
Phase 3Completed

A Study in Japanese Children With Short Bowel Syndrome Who Completed SHP633-302

Start: Aug 2017Est. completion: Nov 20219 patients
Phase 3Completed

Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support

Start: Jan 2017Est. completion: Jan 202010 patients
Phase 3Completed

Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)

Start: Jan 2017Est. completion: Nov 202061 patients
Phase 3Completed

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Start: Dec 2016Est. completion: Jul 202029 patients
Phase 3Completed

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

Start: Jun 2016Est. completion: Aug 201759 patients
Phase 3Completed

Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)

Start: Dec 2014Est. completion: Nov 201811 patients
Phase 3Completed

A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021

Start: May 2012Est. completion: Jul 201314 patients
Phase 3Completed

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Start: Sep 2009Est. completion: Jan 201388 patients
Phase 3Completed

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

Start: Nov 2008Est. completion: Jan 201186 patients
Phase 3Completed

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

Start: Jan 2005Est. completion: Jan 200865 patients
Phase 3Completed

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

Start: May 2004Est. completion: Jul 200784 patients
Phase 3Completed

Safety and Efficacy of ALX-0600 in Subjects With Active Crohn's Disease

Start: Nov 2003Est. completion: Jul 2005100 patients
Phase 2Completed

A Study of Siremadlin Alone and in Combination With Donor Lymphocyte Infusion in Acute Myeloid Leukemia Post-allogeneic Stem Cell Transplant

Start: Feb 2023Est. completion: Oct 20238 patients
Phase 1/2Terminated

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Start: Sep 2019Est. completion: Aug 202445 patients
Phase 1/2Terminated

Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

Start: Dec 2025Est. completion: Mar 202632 patients
Phase 1Recruiting

A Clinical Study of MK-8527 in Participants With Mild and Moderate Hepatic Impairment (MK-8527-015)

Start: Sep 2025Est. completion: Feb 202618 patients
Phase 1Completed

An Investigational Study of ESK-001 in Participants With Normal Liver Function and Participants With Mild, Moderate, and Severe Liver Damage

Start: Apr 2025Est. completion: Dec 202548 patients
Phase 1Recruiting
NCT06908954IpsenPalovarotene

A Study of the Blood Levels of Palovarotene in Participants With Abnormal Liver Function Compared to Healthy Adult Participants After Intake of a Single Dose

Start: Mar 2025Est. completion: Feb 202631 patients
Phase 1Completed

Pharmacokinetics of TNO155 in Participants With Mild, Moderate, or Severe Hepatic Impairment Compared to Matched Healthy Participants

Start: Mar 2025Est. completion: Jun 20250
Phase 1Withdrawn

Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of AZD5004

Start: Dec 2024Est. completion: Oct 202533 patients
Phase 1Completed

Effects of Hepatic Impairment on the Pharmacokinetics of Dazucorilant

Start: Oct 2024Est. completion: Dec 202419 patients
Phase 1Completed

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Start: Sep 2024Est. completion: Mar 202612 patients
Phase 1Recruiting

A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment

Start: Apr 2024Est. completion: Sep 202518 patients
Phase 1Completed

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

Start: Nov 2023Est. completion: Mar 2024
Phase 1Completed

A Study About Fazirsiran in People With and Without Liver Problems

Start: Oct 2023Est. completion: Sep 202534 patients
Phase 1Completed

A Study of TAK-279 in Adults With or Without Liver Damage

Start: Sep 2023Est. completion: Apr 202427 patients
Phase 1Completed

A Research Study Looking at How a Single Dose of the Study Medicine NNC0194-0499 Behaves in Participants With Reduced Liver Function Compared to Participants With Normal Liver Function

Start: Jul 2023Est. completion: Dec 202433 patients
Phase 1Completed

A Phase I Study to Investigate the Effect of Hepatic Impairment on the PK, Safety, and Tolerability of AZD2693.

Start: Jun 2023Est. completion: Sep 202435 patients
Phase 1Completed

A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body

Start: Apr 2023Est. completion: Dec 202432 patients
Phase 1Completed

Pharmacokinetics of Mitiperstat in Participants With Hepatic Impairment

Start: Mar 2023Est. completion: Nov 202431 patients
Phase 1Completed
NCT05684653InnoCareOrelabrutinib Tablets

Study to Evaluate Orelabrutinib Tablets in Subjects With Hepatic Impairment and Healthy Subject

Start: Mar 2023Est. completion: Dec 202334 patients
Phase 1Unknown
NCT06126575Stemline TherapeuticsElacestrant dihydrochloride

A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Start: Mar 2023Est. completion: Nov 202416 patients
Phase 1Completed

Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects

Start: Feb 2023Est. completion: Feb 202422 patients
Phase 1Completed

Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function

Start: Dec 2022Est. completion: Aug 2023
Phase 1Completed

Pharmacokinetics and Safety Study of Siremadlin (HDM201) in Participants With Mild, Moderate and Severe Hepatic Impairment

Start: Dec 2022Est. completion: Sep 202338 patients
Phase 1Completed

A Clinical Trial of the Study Medicine (Called Fosmanogepix) in Participants With Varying Degrees of Hepatic Function.

Start: Oct 2022Est. completion: Oct 2025
Phase 1Completed

A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Brensocatib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment

Start: Oct 2022Est. completion: Jun 202330 patients
Phase 1Completed

Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434

Start: Sep 2022Est. completion: Apr 2027
Phase 1Recruiting

A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment

Start: Sep 2022Est. completion: May 202325 patients
Phase 1Completed

A Study to Assess Safety of Cedirogant and How Cedirogant Moves Through the Body in Adult Participants With Mild, Moderate and Severe Hepatic Impairment

Start: Jul 2022Est. completion: Nov 20226 patients
Phase 1Terminated

A Study of Siremadlin in Combination With Venetoclax Plus Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Chemotherapy.

Start: May 2022Est. completion: Apr 202414 patients
Phase 1Terminated

Fruquintinib Hepatic Impairment Study

Start: Mar 2022Est. completion: Oct 202216 patients
Phase 1Completed

A Study of ASP0367 in People With Kidneys That do Not Work Well and in Healthy People

Start: Dec 2021Est. completion: Nov 202213 patients
Phase 1Completed

Pharmacokinetics Study of FIA586 in Participants With Mild and Moderate Hepatic Impairment

Start: Dec 2021Est. completion: Jun 202254 patients
Phase 1Completed

A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

Start: Sep 2021Est. completion: Jan 202225 patients
Phase 1Completed

Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332

Start: Aug 2021Est. completion: Dec 202117 patients
Phase 1Completed

Related Jobs in Gastroenterology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

5 actively recruiting trials targeting 1,419 patients
30 companies competing in this space