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  • TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Details:

Vonoprazan is a novel potassium-competitive acid blocker (PCAB). It inhibits gastric acid secretion by acting as a reversible competitive inhibitor against potassium ions.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pack

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Phathom Pharmaceuticals

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 24, 2022

Details:

VOQUEZNA® TRIPLE PAK® (vonoprazan, amoxicillin, clarithromycin) contain vonoprazan, an oral small molecule potassium-competitive acid blocker (PCAB) co-packaged with antibiotics. It has been approved by FDA for the treatment of H. pylori infection in adults.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pak

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 30, 2023

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Details:

RHB-204 (clarithromycin) is a 70s Bacterial ribosome inhibitor combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

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 May 22, 2023

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Details:

The Company intends to use the net proceeds for the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering April 03, 2023

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Details:

The net proceeds will be used in the development of RHB-204, a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 30, 2023

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Details:

RHB-204 (clarithromycin) is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine, developed for the treatment of pulmonary NTM disease caused by Mycobacterium avium Complex (MAC).


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Undisclosed

Deal Size: $6.0 million Upfront Cash: Undisclosed

Deal Type: Private Placement March 08, 2023

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Details:

RHB-204 is a Phase 3-stage proprietary, xed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM disease caused by MAC.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

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 January 26, 2023

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Details:

RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, developed for the treatment of pulmonary NTM infections caused by Mycobacterium avium Complex (MAC).


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

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 17, 2022

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Details:

Voquezna (vonoprazan) new treatment options contain antibiotics conveniently packaged with vonoprazan, a novel potassium-competitive acid blocker (PCAB) and the first innovative acid suppressant from a new drug class approved in the U.S. in over 30 years.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Phathom Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2022

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Details:

VOQUEZNA TRIPLE PAK (vonoprazan, amoxicillin, clarithromycin) is an orally administered potassium-competitive acid blocker from a new class of acid suppressant agents and under development for treatment of erosive esophagitis and non-erosive gastroesophageal reflux disease.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Voquezna Triple Pack

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 24, 2022

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Details:

The signing of this agreement both validates the belief in the blockbuster opportunity of Voquenza (vonoprazan) and provides near-term, non-dilutive funding for continued development activities and upcoming commercial launch.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Voquenza

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Morgan Stanley & Co.

Deal Size: $260.0 million Upfront Cash: $100.0 million

Deal Type: Agreement May 04, 2022

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Details:

Vaquezna (vonoprazan)TRIPLE and DUAL PAKs each contain vonoprazan, a novel, first-in-class potassium-competitive acid blocker, and have demonstrated superior eradication rates vs. lansoprazole-based triple therapy in overall patient population of pivotal Phase 3 trial.


Lead Product(s): Vonoprazan Fumarate,Amoxicillin Trihydrate,Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Vaquezna Triple Pak

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 03, 2022

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Details:

Alembic's Clarithromycin is therapeutically equivalent to AbbVie Inc's Biaxin Filmtab Tablets, antimicrobial indicated to treat mild to moderate infections caused by designated, susceptible bacteria.


Lead Product(s): Clarithromycin

Therapeutic Area: Infections and Infectious Diseases Product Name: Clarithromycin-Generic

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 01, 2022

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Details:

U.S. patents for opaganib combination for the treatment of Ebola virus disease provides patent protection until 2035. Opaganib also undergoing two oncology Phase 2 U.S. studies as well as several development programs for inflammatory and viral indications, including Ebola.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Gastroenterology Product Name: RHB-104

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 23, 2021

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Details:

RedHill's key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $35.0 million Upfront Cash: Undisclosed

Deal Type: Financing March 02, 2021

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Details:

The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Gastroenterology Product Name: RHB-104

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: $10.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering March 01, 2021

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Details:

The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Gastroenterology Product Name: RHB-204

Highest Development Status: Phase IIIProduct Type: Small molecule

Partner/Sponsor/Collaborator: H.C. Wainwright & Co.

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Public Offering January 11, 2021

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Details:

RedHill recently initiated a Phase 3 study evaluating the safety and efficacy of RHB-204 as a first-line treatment for pulmonary NTM disease, to be conducted at up to 40 sites across the U.S.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: RHB-204

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 January 06, 2021

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Details:

RHB-204 is being evaluated as a first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease - a rare condition with no FDA-approved first-line therapy.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

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 November 20, 2020

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Details:

Orphan Drug Designation, along with RHB-204’s FDA QIDP priority designation, will extend U.S. potential market exclusivity to a total of 12 years.


Lead Product(s): Clarithromycin,Rifabutin,Clofazimine

Therapeutic Area: Infections and Infectious Diseases Product Name: RHB-204

Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 14, 2020

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