X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
Details:
Discovered and developed by AbbVie scientists, RINVOQ is an oral, once daily, selective and reversible JAK inhibitor studied in several immune-mediated inflammatory diseases. It was engineered to have greater inhibitory potency for JAK1 versus JAK2, JAK3 and TYK2.
Lead Product(s): Upadacitinib,Methotrexate
Therapeutic Area: Immunology Product Name: Rinvoq
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 17, 2021
Swiss Biotech Day
Not Confirmed
Contact SupplierDetails:
RINVOQ (15 mg, once daily) is the first oral, once-daily, selective and reversible JAK inhibitor approved for three adult rheumatic indications in the European Union: rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
Lead Product(s): Upadacitinib,Methotrexate
Therapeutic Area: Immunology Product Name: Rinvoq
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 25, 2021
Swiss Biotech Day
Not Confirmed
Contact SupplierDetails:
In its guidance, NICE recommends upadacitinib, in combination with methotrexate for people with severe active RA, where their disease has responded inadequately to, or they are intolerant to at least two conventional disease-modifying anti-rheumatic drugs (DMARDs).
Lead Product(s): Upadacitinib,Methotrexate
Therapeutic Area: Immunology Product Name: Rinvoq
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 06, 2020
Swiss Biotech Day
Not Confirmed
Contact SupplierDetails:
Long-term results from the SELECT-COMPARE and SELECT MONOTHERAPY studies showed that RINVOQ™ (upadacitinib, 15 mg) continued to improve signs and symptoms in patients with rheumatoid arthritis through 72 and 84 weeks, respectively.
Lead Product(s): Upadacitinib,Methotrexate
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 June 04, 2020
Swiss Biotech Day
Not Confirmed
Contact SupplierDetails:
LX-101, a novel clinical-stage targeted therapy directed to the insulin-like growth factor 1 receptor. It is being investigated in IGF-1R related malignancies and Thyroid eye disease.
Lead Product(s): LX-101,Methotrexate
Therapeutic Area: Oncology Product Name: LX-101
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 14, 2024
Details:
Metoject subcutaneous injection pen (methotrexate) works by inhibiting dihydrofolic acid reductase enzyme. It is approved for the treatment of rheumatoid arthritis.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Metoject
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nippon Medac
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2024
Details:
Jylamvo (methotrexate) is a DHFR inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of acute lymphoblastic leukemia in adults.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: Jylamvo
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 19, 2023
Details:
ATI-450 (zunsemetinib) is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor for the treatment of Moderate to Severe Rheumatoid Arthritis.
Lead Product(s): Zunsemetinib,Methotrexate
Therapeutic Area: Immunology Product Name: ATI-450
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 13, 2023
Details:
Through the acquisition, Shorla gains Jylamvo, an oncology and autoimmune drug and easy-to-administer, sweet tasting oral methotrexate solution that eliminates the need for crushing or splitting pills, or compounding into a liquid formulation, for the US market.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Jylamvo
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Shorla Oncology
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition October 31, 2023
Details:
Under the agreement, Superior Biologics will distribute Yusimry (adalimumab-aqvh), a biosimilar of Humira (adalimumab) and a TNF blocker approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa, in USA.
Lead Product(s): Adalimumab-aqvh,Methotrexate
Therapeutic Area: Gastroenterology Product Name: Yusimry
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Coherus Biosciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement July 13, 2023
Details:
ADX-2191 (methotrexate) is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates the clearance of misfolded rhodopsin, a critical visual cycle protein susceptible to genetic mutation.
Lead Product(s): Methotrexate
Therapeutic Area: Genetic Disease Product Name: ADX‑2191
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 29, 2023
Details:
ADX-2191, a novel formulation of intravitreal injection methotrexate for the potential treatment of proliferative vitreoretinopathy and retinitis pigmentosa.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: ADX-2191
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 21, 2023
Details:
ATI-450 (zunsemetinib) is an investigational oral mitogen-activated protein kinase-activated protein kinase 2 (MK2) inhibitor for the treatment of Moderate to Severe Rheumatoid Arthritis.
Lead Product(s): Zunsemetinib,Methotrexate
Therapeutic Area: Immunology Product Name: ATI-450
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 13, 2023
Details:
ADX-2191 is a novel intravitreal formulation of methotrexate, which in preclinical models of retinitis pigmentosa facilitates the clearance of misfolded rhodopsin, a critical visual cycle protein susceptible to genetic mutation.
Lead Product(s): Methotrexate
Therapeutic Area: Genetic Disease Product Name: ADX‑2191
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 16, 2023
Details:
ADX-2191 (methotrexate) is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: ADX-2191
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 March 02, 2023
Details:
ADX-2191 (methotrexate injection, USP) is a sterile, non-compounded intravitreal formulation of methotrexate for the potential prevention or treatment of rare retinal diseases, including primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa.
Lead Product(s): Methotrexate
Therapeutic Area: Ophthalmology Product Name: ADX‑2191
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 December 21, 2022
Details:
ADX-2191 (methotrexate injection) is a sterile, non-compounded intravitreal formulation for the potential prevention or treatment of specific rare retinal diseases, including primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: ADX-2191
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 December 01, 2022
Details:
Metoject will be the first self-administrable MTX subcutaneous injection formulation for rheumatoid arthritis in Japan. It is approved in approximately 50 countries, primarily in Europe.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Metoject
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Nippon Medac Co.
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2022
Details:
The co-administration of KRYSTEXXA (pegloticase) with an immunomodulator like methotrexate has increasingly been employed in patients with uncontrolled gout to help reduce the development of antidrug antibodies, which can affect treatment efficacy with biologics.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 08, 2022
Details:
GSK3196165 (otilimab) is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage colony-stimulating factor) that is developed by GSK for the treatment of rheumatoid arthritis.
Lead Product(s): Otilimab,Methotrexate,Sulfasalazine
Therapeutic Area: Immunology Product Name: GSK3196165
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
ADX-2191 (methotrexate injection) for intravitreal administration, is in development for the prevention of proliferative vitreoretinopathy and the treatment of retinitis pigmentosa and primary vitreoretinal lymphoma.
Lead Product(s): Methotrexate
Therapeutic Area: Ophthalmology Product Name: ADX-2191
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 05, 2022
Details:
Primary endpoint of ACR20 response* at 12 weeks was 59.6% in Metoject (Methotrexate) group versus 51.0% in oral MTX group, indicating comparable efficacy. Adverse drug reaction incidence rates in this trial were 25.0% in the Metoject group and 34.0% in the oral MTX group.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Metoject
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 26, 2022
Details:
Approval of citrate-free, high-concentration HADLIMA™ (adalimumab-bwwd), TNF blocker indicator was based on clinical data from study that compare PK, safety, tolerability, and immunogenicity of two formulations of HADLIMA (100 mg/mL vs 50 mg/mL) in healthy volunteers.
Lead Product(s): Adalimumab,Methotrexate
Therapeutic Area: Immunology Product Name: Hadlima
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Organon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2022
Details:
The MIRROR randomized controlled trial outcomes provided a clear view of improvements in patient response and reductions in infusion reactions for KRYSTEXXA plus low-dose (15 mg/week) methotrexate compared to KRYSTEXXA plus placebo.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
KRYSTEXXA® (pegloticase injection) is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 24, 2022
Details:
Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in pediatric enthesitis-related arthritis (ERA) and psoriatic arthritis (PsA) patients in the EU.
Lead Product(s): Secukinumab,Methotrexate
Therapeutic Area: Immunology Product Name: Cosentyx
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 20, 2022
Details:
Methotrexate is considered a cornerstone therapy for patients with rheumatoid arthritis (RA), with well-established safety and efficacy profiles and support in international guidelines.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Nordimet
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 29, 2022
Details:
ADX-2191 (intravitreal methotrexate 0.8%), an investigational new drug product, inhibits cellular replication and activation. In vivo research has identified activity of methotrexate in misfolded rhodopsin clearance, suggesting potential to treat forms of retinitis pigmentosa.
Lead Product(s): Methotrexate
Therapeutic Area: Genetic Disease Product Name: ADX-2191
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 March 08, 2022
Details:
Application based on recent MIRROR randomized controlled trial results, which showed 71% of patients randomized to receive KRYSTEXXA (pegloticase), a PEGylated uric acid specific enzyme plus methotrexate achieved a complete response.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 07, 2022
Details:
The PAS was supported by positive topline data from the REFLECTIONS B538-12 study which evaluated multiple switches between treatment with ABRILADA and its reference product, Humira, both of which were administered with methotrexate in adult patients with rheumatoid arthritis.
Lead Product(s): Adalimumab,Methotrexate
Therapeutic Area: Immunology Product Name: Abrilada
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2022
Details:
sBLA Submission based on recent results from the MIRROR randomized clinical trial, which showed a 71% response rate for patients randomized to receive KRYSTEXXA (Pegloticase) PEGylated uric acid specific enzyme, plus methotrexate for people living with uncontrolled Gout.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Rheumatology Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 10, 2022
Details:
Phase 3 GUARD Trial of ADX-2191 (intravitreal methotrexate 0.8%) clinical results suggest that it may diminish the rates of retinal detachment and improve visual outcomes in thousands of patients who undergo surgery for PVR.
Lead Product(s): Methotrexate
Therapeutic Area: Ophthalmology Product Name: ADX-2191
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 04, 2022
Details:
Theramex has entered into an agreement with Enzene Biosciences to develop, register and commercialise a biosimilar drug of Roche’s reference medicine RoActemra® (Tocilizumab). Tocilizumab will be available in parenteral vials, subcutaneous prefilled syringes and autoinjectors.
Lead Product(s): Tocilizumab,Methotrexate
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Theramex
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 23, 2021
Details:
Under the terms of the definitive agreements, Assertio acquired Otrexup from Antares in a partially seller financed transaction inclusive of working capital investments. Otrexup is a once weekly single dose auto-injector containing a prescription medicine, methotrexate.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: Otrexup
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Assertio Holdings
Deal Size: $44.0 million Upfront Cash: $18.0 million
Deal Type: Acquisition December 15, 2021
Details:
U.S. Food and Drug Administration Approves Orencia® (abatacept) in Combination with a Calcineurin Inhibitor and Methotrexate for the Prevention of Acute Graft Versus Host Disease (aGvHD) in Patients Undergoing Hematopoietic Stem Cell Transplant Donor.
Lead Product(s): Abatacept,Methotrexate,Undisclosed
Therapeutic Area: Immunology Product Name: Orencia
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 15, 2021
Details:
The results from the completed PROTECT trial (NCT04087720) demonstrated that Krystexxa (Pegloticase & Methotrexate) provide a substantial and sustained decrease in serum uric acid (sUA) for patients with uncontrolled gout who had received a kidney transplant.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2021
Details:
The findings indicated that the use of KRYSTEXXA with an immunomodulator may improve persistence to therapy. Approx 90% of the evaluated population met the sUA treatment target and those who received immunomodulation after starting on KRYSTEXXA were less likely to discontinue.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 01, 2021
Details:
Results show that 71% (71 of 100) of patients who were randomized to receive KRYSTEXXA with methotrexate compared to 40% (21 of 52) of patients who were randomized to receive KRYSTEXXA with placebo achieved the primary endpoint (p<0.001).
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 25, 2021
Details:
RediTrex (methotrexate) is a folate analog metabolic inhibitor is a new line of pre-filled syringes specifically designed for ease of handling and dosing accuracy for the subcutaneous administration of methotrexate in patients with arthritis and psoriasis.
Lead Product(s): Methotrexate
Therapeutic Area: Immunology Product Name: RediTrex
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:
Methotrexate inhibits dihydrofolic reductase, an enzyme involved in cellular replication and activation. In addition to RP, the FDA has granted orphan drug designation to ADX-2191 for the treatment of primary vitreoretinal lymphoma, a rare, aggressive, high-grade cancer.
Lead Product(s): Methotrexate
Therapeutic Area: Genetic Disease Product Name: ADX-2191
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 August 04, 2021
Details:
ADX-2191 (methotrexate for intravitreal injection) inhibits dihydrofolate reductase, an enzyme involved in cellular replication and activation. Methotrexate is the most commonly used intravitreal medication for the treatment of PVRL.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: ADX-2191
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, 2021
Details:
Phase III JUNIPERA study met its primary endpoint, with Cosentyx® (secukinumab) showing significantly longer time to flare (longer time to worsening of symptoms1) vs placebo (P<.001) in pediatric patients with two subtypes of juvenile idiopathic arthritis (JIA).
Lead Product(s): Secukinumab,Methotrexate
Therapeutic Area: Immunology Product Name: Cosentyx
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2021
Details:
The Reducing Immunogenicity of Pegloticase trial showed that 86% of patients receiving co-therapy of KRYSTEXXA with the immunomodulator mycophenolate mofetil achieved serum uric acid (sUA) ≤ 6 mg/dL at 12 weeks vs 40% of patients (4 of 10) receiving KRYSTEXXA monotherapy.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: University of Michigan
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 07, 2021
Details:
The current recommended dosing of KRYSTEXXA for adult patients is 8 mg given as intravenous infusions every two weeks, with each dose infused over at least two hours.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 25, 2021
Details:
The Company announced two new KRYSTEXXA development programs: KRYSTEXXA, with methotrexate monthly dosing trial and a KRYSTEXXA retreatment trial evaluating KRYSTEXXA, with methotrexate, in patients who have previously failed KRYSTEXXA.
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2021
Details:
The medications under the agreement are Methotrexate Injection; Phytonadione Injectable Emulsion; Ceftriaxone for Injection; Labetalol Hydrochloride Injection; Midazolam Injection; Milrinone Lactate Injection; and Vancomycin Hydrochloride for Injection.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Pfizer Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 03, 2020
Details:
An ongoing arm of the study triggered by the difficult circumstances created by the COVID-19 pandemic is exploring the planned use of Voraxaze® (glucarpidase) to enable high dose MTX treatment of CNSL on an outpatient basis.
Lead Product(s): Glucarpidase,Methotrexate
Therapeutic Area: Neurology Product Name: Voraxaze
Highest Development Status: Phase IProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 12, 2020
Details:
In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or MTX.
Lead Product(s): Filgotinib,Methotrexate
Therapeutic Area: Immunology Product Name: Jyseleca
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 25, 2020
Details:
In the open-label trial, 79 percent of patients who received both KRYSTEXXA and methotrexate (11 of 14 enrolled patients) maintained therapeutic response during Month 6 (defined as sUA <6 mg/dL).
Lead Product(s): Pegloticase,Methotrexate
Therapeutic Area: Musculoskeletal Product Name: Krystexxa
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2020
Details:
The research highlights a Methotrexate-loaded microvesicles tumor therapy for cholangiocarcinoma, approved for clinical use has shown significant efficacy and safety in the treatment of cholangiocarcinoma.
Lead Product(s): Methotrexate
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: UndisclosedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
