X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
LIVMARLI® (maralixibat) oral solution is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor which received FDA approval for treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Details:
Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, which is under phase 2 clinical development for the treatment of Biliary Atresia.
Lead Product(s): Maralixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Livmarli
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 18, 2023
Details:
Livmarli (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor and NMPA has accepted the New Drug Application for the treatment of Cholestatic Pruritus in Progressive Familial Intrahepatic Cholestasis.
Lead Product(s): Maralixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Livmarli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 17, 2023
Details:
Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor being developed for the treatment of biliary atresia in infant who have previously undergone a hepatoportoenterostomy.
Lead Product(s): Maralixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Livmarli
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 11, 2023
Details:
Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. FDA for the treatment of cholestatic pruritus in patients with alagille syndrome one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 05, 2023
Details:
Livmarli™ (maralixibat) is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (primarily the salt forms) from the terminal ileum.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2023
Details:
Livmarli® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. FDA for the treatment of cholestatic pruritus in patients with alagille syndrome one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 14, 2023
Details:
LIVMARLI® (maralixibat) oral solution which is approved in the U.S. for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older, and in Europe for the same indication in patients two months of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Dermatology Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 13, 2022
Details:
Livmarli (maralixibat) is a minimally absorbed ileal bile acid transporter (IBAT) inhibitor that blocks the enterohepatic circulation of bile acids, reduces bile acid levels in the liver and serum, reduces the resultant liver injury and relieves pruritus.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CANbridge Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2022
Details:
LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor, with progressive familial intrahepatic cholestasis (PFIC) in a broad range of subtypes, age one to 17 years.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 24, 2022
Details:
LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 18, 2022
Details:
CHMP opinion based on pivotal ICONIC study with more than five years of data demonstrating durable and clinically meaningful improvements in cholestatic pruritus and serum bile acids for patients with Alagille syndrome (ALGS).
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: NeoPharm Co., Ltd.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2022
Details:
LIVMARLI (maralixibat) oral solution is an orally administered, once-daily, IBAT inhibitor approved by the U.S. FDA for the treatment of cholestatic pruritus in patients with ALGS one year of age and older and is the only FDA-approved medication to treat cholestatic pruritus.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2022
Details:
LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, IBAT inhibitor for the treatment of cholestatic pruritus in patients with ALGS one year of age and older and is the only FDA-approved medication to treat cholestatic pruritus associated with ALGS.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2022
Details:
CAN108 (maralixibat) oral solution is an orally administered, once-daily,IBAT inhibitor approved by USFDA for treatment of cholestatic pruritus in patients with Alagille syndrome (one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: CAN108
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mirum Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 14, 2022
Details:
The analysis demonstrated a highly significant improvement in six-year event-free survival with a p-value of <0.0001 (HR: 0.305, 95% CI: 0.189-0.491) translating to a 70% overall reduction for clinical outcomes with Livmarli (maralixibat).
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2022
Details:
LIVMARLI (maralixibat) is an orally administered IBAT inhibitor approved by U.S.FDA for treatment of cholestatic pruritus in patients with ALGS one year of age and older and is the only FDA-approved medication to treat cholestatic pruritus associated with Alagille syndrome.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 13, 2022
Details:
LIVMARLI® (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mirum Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $2.8 million
Deal Type: Acquisition May 23, 2022
Details:
LIVMARLI™ (maralixibat) is a barely absorbed ileal bile acid transporter (IBAT) inhibitor that blocks the enterohepatic circulation of bile acids, reduces bile acid levels in the liver and serum, reduces the resultant liver injury and relieves pruritus.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mirum Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Livmarli (maralixibat), barely absorbed IBAT inhibitor has been approved under early and pilot implementation policy in boao lecheng , which will allow it to be imported and used as an urgently needed drug in the region for treatment of ALGS.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
LIVMARLI™ (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jefferies LLC
Deal Size: $110.0 million Upfront Cash: Undisclosed
Deal Type: Agreement November 17, 2021
Details:
LIVMARLI™ is an orally administered ileal bile acid transporter (IBAT) inhibitor for the treatment of cholestatic pruritus in patients with Alagille syndrome is currently being evaluated in clinical trials for pediatric liver diseases.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Maralixibat is an ileal bile acid transporter (IBAT) inhibitor that interrupts enterohepatic bile acid recirculation has potential to provide a new treatment paradigm for patients with ALGS.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
LIVMARLI™ (maralixibat) oral solution is an orally administered, once-daily, ileal bile acid transporter (IBAT) inhibitor approved by the U.S. Food and Drug Administration for the treatment of cholestatic pruritus in patients with Alagille syndrome one year of age and older.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Livmarli
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 29, 2021
Details:
Under the terms of the agreement, Takeda will be responsible for regulatory approval and commercialization of maralixibat in Japan. Takeda will also be responsible for development, including conducting clinical studies in cholestatic indications.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mirum Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 21, 2021
Details:
The ICONIC data is supported by a new analysis, which includes an aggregated cohort of maralixibat-treated patients with ALGS (n=84) compared to a natural history control cohort, demonstrating a statistically significant improvement in six-year event-free survival.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2021
Details:
Under the terms of the licensing agreement, GC Pharma has obtained the exclusive right to develop and commercialize maralixibat within South Korea for ALGS, PFIC, and BA.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: GC Pharma
Deal Size: Undisclosed Upfront Cash: $5.0 million
Deal Type: Licensing Agreement July 26, 2021
Details:
Data from more than five years of maralixibat treatment across three Phase 2 clinical studies were analyzed to assess the overall clinical safety of maralixibat in patients with ALGS (n=86). Maralixibat was well-tolerated for more than five years.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 23, 2021
Details:
Maralixibat targets the apical sodium dependent bile acid transporter (ASBT) ultimately resulting in lower levels of bile acid systemically, which could mediate liver damage. CANbridge will lead development and commercialization in of the product in China.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: CANbridge Pharmaceuticals
Deal Size: $120.0 million Upfront Cash: $11.0 million
Deal Type: Collaboration April 29, 2021
Details:
Results of long-term treatment from the ITCH and IMAGINE II studies presented in late-breaking oral presentation at AASLD. Data Showed a significant and durable improvements in pruritus in children with Alagille syndrome through 220 weeks of maralixibat treatment.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 15, 2020
Details:
Late-breaker oral presentation features long-term data from Phase 2 ITCH and IMAGINE II studies evaluating maralixibat in pediatric patients with Alagille syndrome.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 02, 2020
Details:
The Company has initiated a rolling NDA submission for maralixibat in the treatment of patients with cholestatic pruritus associated with ALGS and expects to complete the submission in the first quarter of 2021.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 26, 2020
Details:
Mirum will utilize EVERSANA’s commercialization platform to provide integrated nationwide distribution, specialty pharmacy, patient services and Hub support for maralixibat, if approved.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Mirum Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership October 15, 2020
Details:
Maralixibat is a novel, minimally absorbed, orally administered apical sodium dependent bile acid transporter (ASBT) inhibitor being evaluated for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS).
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: LUM001
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 01, 2020
Details:
Maralixibat demonstrates significant transplant-free survival for patients with progressive familial intrahepatic cholestasis (PFIC2) who achieved serum bile acid (sBA) control in five-year analysis.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2020
Details:
Maralixibat-treated patients achieving serum bile acid control have five-year native liver survival after treatment.
Lead Product(s): Maralixibat
Therapeutic Area: Genetic Disease Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
