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Details:
This next-generation adenine nucleotide translocase (ANT) inhibitor, PENAO, was shown to be safe and well-tolerated in a phase I clinical trial conducted in Australia where encouraging efficacy data was observed.
Lead Product(s): PENAO,Sirolimus
Therapeutic Area: Oncology Product Name: PENAO
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: PENAO Pty Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement August 18, 2021
Iran Expo
Not Confirmed
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Details:
FDA gave IDE approval for MagicTouch AVF, its Sirolimus drug-coated balloon (DCB) catheter, to initiate a clinical study for the treatment of stenotic lesions of Arteriovenous Fistula in the Haemodialysis management of Chronic Renal Failure.
Lead Product(s): Sirolimus
Therapeutic Area: Nephrology Product Name: MagicTouch AVF
Highest Development Status: IND EnablingProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 02, 2024
Details:
The partnership aims to accelerate Phase 3 development of Qtorin™ rapamycin for the treatment of Microcystic Lymphatic Malformations (Microcystic LMs).
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Qtorin
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Ligand Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $5.0 million
Deal Type: Partnership December 01, 2023
Details:
Qtorin (rapamycin) is a macrocyclic lactone antibiotic produced by bacteria Streptomyces hygroscopicus. It is being evaluated for the treatment of microcystic lymphatic malformations.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Qtorin
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 16, 2023
Details:
Selution SLR (Sirolimus drug-eluting balloon) completion of patient enrollment in the SAVE Clinical Trial in patients with failed AVF (arteriovenous fistulas) in renal dialysis patients.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SELUTION SLR
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 14, 2023
Details:
SELUTION SLR (Sirolimus drug-eluting balloon) completion of patient enrollment in the SAVE Clinical Trial in patients with failed AVF (arteriovenous fistulas) in renal dialysis patients.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SELUTION SLR
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 05, 2023
Details:
LAM-001 (sirolimus) is a proprietary, investigational, inhaled formulation of sirolimus, which is investigated in Patients With pulmonary arterial hypertension.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LAM-001
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 August 31, 2023
Details:
The financing will be used to accelerate clinical development of next-generation SirPlux duo drug-coated balloon (DCB) which combines the synergistic power of sirolimus and paclitaxel to create a next-generation, front-line therapy for treating de novo coronary artery disease.
Lead Product(s): Sirolimus,Paclitaxel
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SirPlux Duo DCB
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $4.0 million Upfront Cash: Undisclosed
Deal Type: Series A Financing August 22, 2023
Details:
LAM-001 (sirolimus) is a proprietary, investigational, inhaled formulation of sirolimus, which is investigated in Patients With Bronchiolitis Obliterans Syndrome (BOS) Post-Lung Transplant.
Lead Product(s): Sirolimus
Therapeutic Area: Immunology Product Name: LAM-001
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 August 18, 2023
Details:
SELUTION SLR 018 DEB (Sirolimus drug-eluting balloon) completion of patient enrollment in the SAVE Clinical Trial in patients with failed AVF (arteriovenous fistulas) in renal dialysis patients.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SELUTION SLR 018 DEB
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 15, 2023
Details:
Virtue SAB (sirolimusEFR), a proprietary, investigational, extended release formulation of sirolimus, to the artery during balloon angioplasty without the need for balloon coating or a permanent implant.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Virtue SAB
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2023
Details:
Qtorin (rapamycin) a topical mTOR inhibitor, which is being investigated for the treatment of microcystic lymphatic malformations and in individuals with basal cell carcinomas (BCCs) in gorlin syndrome (GS).
Lead Product(s): Sirolimus
Therapeutic Area: Genetic Disease Product Name: Qtorin
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 July 20, 2023
Details:
Qtorin (rapamycin), a topical mTOR inhibitor and the lead product candidate from the QTORIN™ platform, is being investigated in Phase 3 clinical trial for the treatment of Pachyonychia Congenita (PC).
Lead Product(s): Sirolimus
Therapeutic Area: Genetic Disease Product Name: Qtorin
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 July 20, 2023
Details:
The IDE approval will allow Concept Medical to initiate pivotal clinical study to demonstrate safety and effectiveness of the MagicTouch PTA Sirolimus coated balloon in femoral and popliteal segments for the treatment of Superficial Femoral Arteries.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch PTA
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 29, 2023
Details:
MagicTouch SCB is the world’s first Sirolimus-coated Balloon with extensive commercial usage or for the treatment of Small Vessels (SV) in coronary arteries, in Europe, major markets of Asia and the Mid-Eastern markets.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch SCB
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 28, 2023
Details:
Hyftor (sirolimus) is indicated for the treatment of facial angiofibroma associated with tuberous sclerosis in patients with age of 6 years and older. Sirolimus works by inhibiting T-lymphocyte activation and proliferation stimulated by antigens and cytokines.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Hyftor
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:
Qtorin™ (rapamycin) is the lead product candidate from Palvella’s QTORIN™ platform and is initially under evaluation for for the treatment of individuals with Pachyonychia Congenita and Microcystic LM, as well as for the prevention of BCCs in individuals with GS.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Qtorin
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 March 09, 2023
Details:
Virtue SAB (sirolimus), a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. It provides mechanical dilatation (inhibiting the proliferation of cells), with the intended purpose of reducing restenosis.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Virtue SAB
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 24, 2023
Details:
Qtorin™ (rapamycin) is the lead product candidate from Palvella’s QTORIN™ platform and is initially under evaluation for for the treatment of individuals with Pachyonychia Congenita and Microcystic LM, as well as for the prevention of BCCs in individuals with GS.
Lead Product(s): Sirolimus
Therapeutic Area: Genetic Disease Product Name: Qtorin
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 21, 2023
Details:
Sirolimus binds to the immunophilin, FK Binding Protein-12 (FKBP-12), to generate an immunosuppressive complex. It is given to treat a rare lung disorder called lymphangioleiomyomatosis which predominantly affects women of childbearing age.
Lead Product(s): Sirolimus
Therapeutic Area: Immunology Product Name: Sirolimus-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 17, 2023
Details:
Sundance (sirolimus), a potent anti-inflammatory and anti-proliferative compound, has been used successfully in coronary drug-eluting stents. It provides mechanical dilatation (inhibiting the proliferation of cells), with the intended purpose of reducing restenosis.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Sundance
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 19, 2023
Details:
Sundance (sirolimus) is an immunosuppressants which inhibits T-lymphocyte activation and proliferation that occurs in response to antigenic and cytokine (IL-2, IL-4, and IL-15) stimulation. Sirolimus also inhibits antibody production.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Sundance
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 16, 2023
Details:
Proceeds from the financing will be used to advance the development QTORIN rapamycin anhydrous gel for the treatment of Pachyonychia Congenita, treatment of Microcystic Lymphatic Malformations, and for the prevention of Basal Cell Carcinomas in Gorlin Syndrome.
Lead Product(s): Sirolimus
Therapeutic Area: Genetic Disease Product Name: QTORIN
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Petrichor
Deal Size: $37.7 million Upfront Cash: Undisclosed
Deal Type: Series D Financing January 05, 2023
Details:
The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Sundance
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2022
Details:
The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient designed to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Sundance
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2022
Details:
Magic Touch PTA is CE approved and commercially marketed sirolimus DCB, using proprietary Nanolute Technology – drug delivery technology platform of Magic Touch PTA balloon, is designed to deliver sub-micron particles of sirolimus to reach deepest layers of vessel walls.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
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 21, 2022
Details:
By acquiring MedAlliance, Cordis has the potential to serve two million patients globally by 2027 with the SELUTION SLR™ (Sustained Sirolimus Release) drug-eluting balloon for the treatment of coronary artery disease.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Selution SLR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cordis
Deal Size: $1,135.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition October 18, 2022
Details:
The Sundance Sirolimus Drug-Coated Balloon utilizes a next-generation coating technology consisting of microcrystalline sirolimus and a proprietary excipient to maximize drug transfer, enhancing sirolimus delivery and sustaining therapeutic levels in the artery.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Sundance
Highest Development Status: Phase IProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2022
Details:
HYFTOR™ (sirolimus topical gel) 0.2% is the first and only clear topical medication approved by the FDA to treat facial angiofibroma associated with TSC in adults and children 6 years of age and older.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Hyftor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2022
Details:
Emtora plans to use the CPRIT award to complete a multicenter, randomized, placebo-controlled Phase 3 trial of eRapa (rapamycin) in patients with FAP. Patients with FAP are predisposed to the development of hundreds or even thousands of polyps in their gastrointestinal tract.
Lead Product(s): Sirolimus
Therapeutic Area: Oncology Product Name: eRapa
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Cancer Prevention & Research Institute of Texas
Deal Size: $19.9 million Upfront Cash: Undisclosed
Deal Type: Funding August 19, 2022
Details:
HYFTOR™ (sirolimus topical gel) 0.2% is the first and only clear topical medication approved by the FDA to treat facial angiofibroma associated with TSC in adults and children 6 years of age and older.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Hyftor
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 25, 2022
Details:
Under the terms of their collaboration agreement, Orchestra BioMed and Terumo plan to execute a global clinical program Virtue SAB (sirolimus), in an effort to gain regulatory approval for commercial sale of Virtue SAB in multiple markets and indications.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Virtue SAB
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Terumo
Deal Size: Undisclosed Upfront Cash: $30.0 million
Deal Type: Collaboration July 05, 2022
Details:
Funds will be used to complete the first-in-human clinical study in Australia of the SirPlux Duo (paclitaxel and sirolimus) drug-coated balloon (DCB) in de-novo coronary artery disease (CAD) lesions.
Lead Product(s): Paclitaxel,Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: SirPlux Duo
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $7.2 million Upfront Cash: Undisclosed
Deal Type: Series A Financing June 28, 2022
Details:
The aim of the SELUTION4BTK clinical trial is to demonstrate the superior efficacy and equivalent safety of SELUTION SLR (sirolimus) compared to plain (uncoated) balloon angioplasty (POBA) in the treatment of BTK arteries in CLTI (Chronic Limb Threatening Ischemia) patients.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Selution SLR
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 08, 2022
Details:
VIC-1911 is a novel and orally active inhibitor of Aurora A kinase, a key regulator in mitotic cell division and sirolimus specifically designed to substantially reduce GVHD, facilitate full potential of leukemia effect, and maximize GVHD-free, relapse-free survival.
Lead Product(s): VIC-1911,Cyclophosphamide,Sirolimus
Therapeutic Area: Immunology Product Name: VIC-1911
Highest Development Status: Phase I/ Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: University of Minnesota Medical School
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2022
Details:
Hyftor (sirolimus) 0.2% is the first and only clear topical medication approved by the FDA to treat facial angiofibroma associated with TSC in adults and children 6 years of age and older.
Lead Product(s): Sirolimus
Therapeutic Area: Rare Diseases and Disorders Product Name: Hyftor
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 04, 2022
Details:
Magic Touch PTA is a marketed sirolimus coated balloon, developed using proprietary Nanolute Technology– the drug delivery technology platform of Magic Touch PTA balloon, is designed to deliver sub-micron particles of sirolimus to reach the deepest layers of the vessel walls.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: MagicTouch PTA
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Jena University Hospital
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 09, 2022
Details:
Preclinical studies in murine and a naturally-occurring feline model of GM1 gangliosidosis have supported AXO-AAV-GM1’s ability to increase β-galactosidase enzyme activity, reduce GM1 ganglioside accumulation, improve neuromuscular function, and extend survival.
Lead Product(s): AXO-AAV-GM1,Rituximab,Sirolimus
Therapeutic Area: Genetic Disease Product Name: AXO-AAV-GM1
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 21, 2021
Details:
AXO-AAV-GM1, the company’s adeno-associated viral vector (AAV)9-based gene therapy for the treatment of Type I (early infantile onset) and Type II (late infantile and juvenile onset) GM1 gangliosidosis.
Lead Product(s): AXO-AAV-GM1,Rituximab,Sirolimus
Therapeutic Area: Genetic Disease Product Name: AXO-AAV-GM1
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 04, 2021
Details:
The objective of this trial is to evaluate the safety and efficacy of the SELUTION SLR DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb threatening ischemia in 75 patients over 12 months at Singapore General Hospital.
Lead Product(s): Sirolimus
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Selution SLR
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 12, 2021
Details:
The Phase 1 portion of the trial evaluated safety of pacritinib + sirolimus + low-dose tacrolimus after allogeneic hematopoietic cell transplantation. A 3+3 dose escalation design identified PAC 100 mg twice a day was well-tolerated dose for further study.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: PAC
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 March 22, 2021
Details:
Extension of agreement with AFT Pharmaceuticals grants Desitin Arzneimittel GmbH exclusive license and supply rights for TMB-002 in Europe.
Lead Product(s): Sirolimus
Therapeutic Area: Dermatology Product Name: Pascomer
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Timber Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 17, 2021
Details:
Acquisition will set up a gene therapy program at Lilly, based on Prevail's portfolio of neuroscience assets, including the lead candidate, PR001, and will broaden Lilly's commitment to use novel modalities to address fatal genetic forms of neurodegenerative disease.
Lead Product(s): PR001,Methylprednisolone,Sirolimus
Therapeutic Area: Neurology Product Name: PR001
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: $1,040.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition January 22, 2021
Details:
Acquisition will establish a gene therapy program at Lilly, anchored by Prevail's portfolio of neuroscience assets, and will broaden Lilly's commitment to use novel modalities to attempt to address otherwise fatal genetic forms of neurodegenerative disease.
Lead Product(s): PR001,Methylprednisolone,Sirolimus
Therapeutic Area: Neurology Product Name: PR001
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: $1,040.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition December 15, 2020
Details:
Initial data from the ongoing Phase 1/2 study in five patients in the low-dose cohort showed that AXO-AAV-GM1 was generally well tolerated with a favorable safety profile and provide early indications of clinical disease stability.
Lead Product(s): AXO-AAV-GM1,Rituximab,Sirolimus
Therapeutic Area: Genetic Disease Product Name: AXO-AAV-GM1
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: National Human Genome Research Institute
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2020
Details:
PR006 is an investigational AAV9 gene therapy delivering the GRN gene and is being developed as a potential therapy for patients with frontotemporal dementia with GRN mutations.
Lead Product(s): PR006,Methylprednisolone,Sirolimus
Therapeutic Area: Neurology Product Name: PR006
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 30, 2020
Details:
The Company expects to initiate enrollment of the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease patients in the fourth quarter of 2020 and currently anticipates it will provide the next update on PR001 biomarker and safety data for nGD in 2021.
Lead Product(s): PR001,Methylprednisolone,Sirolimus
Therapeutic Area: Neurology Product Name: PR001
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2020
Details:
Abstract titled "Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase I Trial Results" will be presented at the 62nd American Society of Hematology Meeting.
Lead Product(s): Pacritinib,Sirolimus,Tacrolimus
Therapeutic Area: Immunology Product Name: Undisclosed
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 November 04, 2020
Details:
The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD). Prevail expects to start enrollment of the PROVIDE Phase 1/2 clinical trial of PR001 in the second half of 2020.
Lead Product(s): PR001,Methylprednisolone,Sirolimus
Therapeutic Area: Neurology Product Name: PR001
Highest Development Status: Phase I/ Phase IIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2020
Details:
Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Sirolimus Tablets, 0.5 mg, 1 mg and 2 mg, the generic version of Rapamune Tablets, 0.5 mg, 1 mg and 2 mg, of PF Prism CV.
Lead Product(s): Sirolimus
Therapeutic Area: Immunology Product Name: Undisclosed
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 19, 2020
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