Glypressin

(Terlipressin)

ApprovedSmall molecule

Terlipressin is used to treat bleeding from enlarged veins in the esophagus (food pipe) and to help maintain blood pressure in patients with severe liver disease or septic shock.[2] Glypressin is currently approved and in use across 19 indications[4].[1]

Glypressin is one of 335 small molecule programs targeting Acute Kidney Injury. It is currently in Approved.

Indications

Total Trials

Active Trials

334

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Acute Kidney InjuryUnknown status

HypertensionActive, not recruiting

Renal InsufficiencyActive, not recruiting

Benign Muscle NeoplasmActive, not recruiting

Cirrhosis of LiverApproved

Liver FailureApproved

Acute-on-Chronic Liver FailureApproved

Kidney FailureApproved

Gastrointestinal HemorrhageActive, not recruiting

Kidney TransplantActive, not recruiting

Acute Kidney InjuryApproved

Unknown status

HypertensionApproved

Active, not recruiting

Renal InsufficiencyApproved

Active, not recruiting

Benign Muscle NeoplasmPreclinical

Active, not recruiting

Cirrhosis of LiverApproved

Approved

Liver FailureApproved

Approved

Acute-on-Chronic Liver FailureApproved

Approved

Kidney FailureApproved

Approved

Gastrointestinal HemorrhagePreclinical

Active, not recruiting

Kidney TransplantPreclinical

Active, not recruiting

Showing 10 of 19 indications

Competition

Competitive Landscape

242 competitors in Efficacy and Safety

#DrugCompanyPhaseTrials

Glypressin

MMallinckrodt

Approved

1 2

Lutathera

Novartis

Phase 3

1 3

Telitacicept

VVor Biopharma

Phase 3

4 4

Romiplostim N01

Qilu Pharmaceutical Co., Ltd.

Phase 3

1 5

S1,

CChinese Academy of Medical Sciences

Phase 3

1 6

Zvs101e

CChigenovo Co., Ltd

Phase 3

1 7

HSK39297

Haisco Pharmaceutical Group Co., Ltd.

Phase 3

3 8

Imlifidase

HHansa Biopharma AB

Phase 3

2 9

INZ-701

IInozyme Pharma

Phase 3

1 10

IBI302

Innovent Biologics (Suzhou) Co. Ltd.

Phase 3

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Blood Loss

NCT05266534

Q1 2027

PreclinicalNot yet recruiting

Uterine Fibroids

NCT07746349

N/ANot yet recruiting

Liver Transplant

NCT07304466

Q2 2027

PreclinicalActive, not recruiting

Kidney

NCT06855758

Clinical

Trials by Indication[1]

Hepatorenal Syndrome12 trials

Comparison of Terlipressin Versus Octreotide in Patients With Hepatorenal Syndrome

Completed·LLahore General Hospital·N/A·NCT07460908·60 enrolled

A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin

Completed·MMallinckrodt·Phase 3·NCT01143246·196 enrolled

Study to Evaluate R2R01 Plus Terlipressin Versus Terlipressin Alone in Patients With Hepatorenal Syndrome

Unknown status·RRiver 2 Renal Corp.·Phase 2·NCT05875948·95 enrolled

Show 9 more trials

Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1

Completed·MMallinckrodt·Phase 3·NCT02770716·300 enrolled

Terlipressin Infusion Alone Vs Terlipressin With Noradrenaline Infusion In The Treatment of Hepatorenal Syndrome Type 1

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT03822091·60 enrolled

TYPE 2 HEPATORENAL SYNDROME

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT01637454·46 enrolled

The Effect of Terlipressin in the Prevention of Type 2 Hepatorenal Syndrome by Improving Mean Arterial Pressure

Unknown status·SSun Yat-sen University·Phase 4·NCT02489864·30 enrolled

Noradrenalin vs Terlipressin in Hepatorenal Syndrome

Completed·UUniversity of Turin, Italy·Phase 3·NCT00370253·20 enrolled

Treatment of Hepatorenal Syndrome With Terlipressin Plus Albumin vs Albumin

Suspended·HHospital Clinic of Barcelona·Phase 4·NCT00287664·100 enrolled

A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

Completed· Ferring logo

Ferring·Phase 1/2·NCT01373606·8 enrolled

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome

Recruiting·NNoorik Biopharmaceuticals AG·Phase 2·NCT06256432·54 enrolled

Study of Terlipressin Versus Placebo to Treat Hepatorenal Syndrome Type 1

Completed·MMallinckrodt·Phase 3·NCT00089570·112 enrolled

Septic Shock11 trials

Terlipressin Administration in Septic Shock Refractory to Catecholamines

Unknown status·—·Phase 2·NCT00793559·30 enrolled

Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT05315557·100 enrolled

What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

Unknown status·RRamathibodi Hospital·Phase 3·NCT03038503·60 enrolled

Show 8 more trials

Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

Unknown status·AAssistance Publique Hopitaux De Marseille·Phase 4·NCT03336814·40 enrolled

Terlipressin for Refractory Septic Shock

Unknown status·MMahidol University·Phase 2·NCT04339868·130 enrolled

Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04819568·310 enrolled

Continuos Terlipressin Infusion in Septic Shock

Unknown status·FFirst Affiliated Hospital, Sun Yat-Sen University·N/A·NCT01697410·1,000 enrolled

Continuous Infusion of Terlipressin in Septic Shock

Completed·UUniversity of Roma La Sapienza·Phase 2·NCT00481572·45 enrolled

Terlipressin in Septic Shock in Cirrhosis

Completed·HHospital Clinic of Barcelona·Phase 2/3·NCT00628160·72 enrolled

The Effect of Terlipressin on Intesitnal Function in Septic Shock Patients

Unknown status·LLiu ZiMeng·N/A·NCT02306239·40 enrolled

Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT01836224·84 enrolled

Liver Transplant4 trials

Effects of Terlipressin and Somatostatin on Portal Pressure in Patients Undergoing Living Donor Liver Transplantation

Not yet recruiting·IIstanbul Medipol University Hospital·N/A·NCT07304466·50 enrolled

Effect of Terlipressin on Cerebral Oxygen Saturation During Liver Transplantation

Completed·KKasr El Aini Hospital·Phase 2·NCT03395574·30 enrolled

Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)

Completed·UUniversity of Pennsylvania·Phase 3·NCT04460560·50 enrolled

Show 1 more trial

Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney

Completed·NNational Liver Institute, Egypt·Phase 4·NCT02059460·25 enrolled

Efficacy3 trials

Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT03584087·74 enrolled

Efficacy of Continuous Terlipressin Therapy After Endoscopic Variceal Ligation

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 3·NCT06027970·165 enrolled

The Safety & Efficacy of Terlipressin vs Octreotide for the Control of Variceal Bleed

Completed·—·Phase 4·NCT00534677·320 enrolled

Blood Loss3 trials

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Without Using Haemostatic Tourniquets

Recruiting·WWael Elbanna Clinic·N/A·NCT05266534·162 enrolled

The Effect of Intramyometrial Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Open Myomectomy Operations Using Haemostatic Tourniquets:

Completed·WWael Elbanna Clinic·N/A·NCT05242783·99 enrolled

Terlipressin Infusion During Whipple Procedure: Effect on Blood Loss and Transfusion Needs

Completed·—·Phase 2·NCT03572088·40 enrolled

24 more indications

Acute Variceal Bleeding3 trials

Short Course Terlipressin for Control of Acute Variceal Bleeding

Completed·—·Phase 4·NCT00369694·130 enrolled

Functional MRI-based Assessment of Terlipressin vs. Octreotide on Renal Function in Cirrhotic Patients With Acute Variceal Bleeding (CHESS1903)

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT04028323·60 enrolled

To Assess Safety and Efficacy of Bolus Versus Continuous Infusion of Terlipressin in Acute Variceal Bleeding

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02695862·110 enrolled

Laparoscopic2 trials

The Effect of Intramyometrial Injection of Terlipressin Versus Intramyometrial Injection of Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

Recruiting·WWael Elbanna Clinic·N/A·NCT05154279·99 enrolled

The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

Recruiting·WWael Elbanna Clinic·N/A·NCT05170230·99 enrolled

Liver Resection2 trials

Effects of Terlipressin on Blood Loss and Transfusion Requirements During Major Liver Resection.

Completed·—·Phase 2·NCT02588716·84 enrolled

Terlipressin Administration in Patients Undergoing Major Liver Resection

Terminated·IInsel Gruppe AG, University Hospital Bern·Phase 2·NCT01921985·150 enrolled

Cirrhosis2 trials

Efficacy and Safety of Terlipressin With Albumin Versus Midodrine With Albumin Versus Albumin Alone in Prevention of Paracentesis Induced Circulatory Dysfunction in Cirrhosis

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03144713·150 enrolled

Renal and Cardiovascular Effects of Terlipressin in Patients With Cirrhosis and Ascites

Completed·HHvidovre University Hospital·Phase 2/3·NCT00115947

Portal Hypertension2 trials

Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

Unknown status·GGeneral Hospital of Shenyang Military Region·N/A·NCT03130127·40 enrolled

Hemodynamic Profile of Terlipressin and Octreotide in Patients With Cirrhosis and Portal Hypertension. A Randomised, Single Blinded Clinical Trial.

Unknown status·JJuan A. Arnaiz·Phase 4·NCT04353193·36 enrolled

Hemodynamic2 trials

Hemodynamic Effects of Terlipressin and High Dose Octreotide

Completed·SShanghai Zhongshan Hospital·Phase 4·NCT02119884·88 enrolled

Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery

Completed·—·Phase 2·NCT02718599·50 enrolled

Acute Kidney Injury2 trials

Effect of Terlipressin on the Incidence of Early Postoperative Acute Kidney Injury in Liver Transplantation Patients

Unknown status·—·Phase 4·NCT06108362·104 enrolled

Terlipression Prevent Developing of Acute Kidney Injury During Upper-gastroentestinal Bleeding

Completed·—·Phase 4·NCT04358016·54 enrolled

Bleeding1 trial

Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Completed·KKorea University·Phase 4·NCT00966355·1,034 enrolled

Gastrointestinal hemorrhage1 trial

Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage

Completed·GGeneral Hospital of Shenyang Military Region··NCT03846180·1,682 enrolled

Drug1 trial

Vasoactive Drugs in Real World Practice

Completed·KKaohsiung Veterans General Hospital.·Phase 4·NCT02757703·150 enrolled

Chronic Liver Failure1 trial

Safety and Efficacy of Continuous Infusion of Terlipressin With Norepinephrine Versus Norepinephrine Alone in Improving Outcomes of Acute Kidney Injury in Acute on Chronic Liver Failure With Septic Shock

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06556472·126 enrolled

Surgery1 trial

Does Terlipressin Improve Renal Outcome After Liver Surgery

Withdrawn·UUniversity of Zurich·Phase 2·NCT02368249

Statin1 trial

Effects of Terlipressin When Usual Somatostatin or Octreotide Dose Fails

Unknown status·SShanghai Zhongshan Hospital··NCT02311608·1,320 enrolled

Acute-on-Chronic Liver Failure1 trial

Efficacy of Early Terlipressin Plus Albumin Therapy in Comparison to Standard Treatment for HRS-AKI in Acute-on-chronic Liver Failure.

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04416282·70 enrolled

Blood Pressure1 trial

Decision Support for Intraoperative Low Blood Pressure

Completed·VVanderbilt University Medical Center·N/A·NCT02726620·22,435 enrolled

Hemoptysis1 trial

ACid Tranexamic or Terlipressin for Initial Emergency Treatment of Mild to seVere hEmoptysis: a Randomized Trial.

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04961528·315 enrolled

Donor1 trial

Effects of Terlipressin on Management of Potential Organ Donors

Completed·FFirst Affiliated Hospital, Sun Yat-Sen University··NCT03477461·18 enrolled

Hemorrhage1 trial

Terlipressin Infusion in Variceal Hemorrhage

Unknown status·—·Phase 3·NCT04028505·128 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·Phase 2/3·NCT06815770·60 enrolled

Prevention1 trial

Prevention of Esophageal Variceal Rebleeding

Unknown status·NNational Science and Technology Council, Taiwan·Phase 4·NCT00863837·120 enrolled

Ascites1 trial

Terlipressin in Cirrhotic Patients With Recidivation Ascites Treated With Paracentesis and Albumin

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT00986817·82 enrolled

Uterine Fibroids1 trial

Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Not yet recruiting·SSevil Cankaya·Preclinical·NCT07746349·80 enrolled

Liver Neoplasms1 trial

Intraoperative Continuous Terlipressin Infusion is Associated With Reduced Severe Postoperative Complications After Laparoscopic Hepatectomy: a Prospective Propensity Score-matched Cohort Study

Completed·FFirst Affiliated Hospital, Sun Yat-Sen University··NCT07719933·161 enrolled

Kidney1 trial

Effect of Terlipressin for Intraoperative Blood Pressure Management in Kidney Transplantation, A Double-blind Randomized Controlled Trial

Active, not recruiting·BBeijing Friendship Hospital·Preclinical·NCT06855758·150 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 14, 2022

TERLIVAZ

NDA NDA022231

Sources

References

[1]
ClinicalTrials.gov — 65 trial records for Terlipressin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Glypressin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Terlipressin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Terlipressin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022231). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Glypressin. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Mallinckrodt company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vasopressin V1 Receptor Binding Agent; Vasopressin V2 Receptor Binding Agent[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMallinckrodt

Patent Landscape[6]

Patent Cliff

Apr 5, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10335452Apr 5, 2037

Glypressin

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Trials by Indication[1]

Hepatorenal Syndrome12 trials

Septic Shock11 trials

Liver Transplant4 trials

Efficacy3 trials

Blood Loss3 trials

Acute Variceal Bleeding3 trials

Laparoscopic2 trials

Liver Resection2 trials

Cirrhosis2 trials

Portal Hypertension2 trials

Hemodynamic2 trials

Acute Kidney Injury2 trials

Bleeding1 trial

Gastrointestinal hemorrhage1 trial

Drug1 trial

Chronic Liver Failure1 trial

Surgery1 trial

Statin1 trial

Acute-on-Chronic Liver Failure1 trial

Blood Pressure1 trial

Hemoptysis1 trial

Donor1 trial

Hemorrhage1 trial

Efficacy and Safety1 trial

Prevention1 trial

Ascites1 trial

Uterine Fibroids1 trial

Liver Neoplasms1 trial

Kidney1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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