X
API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor and modifying its downstream activity, being developed for the treatment Duchenne muscular dystrophy in 4 years and older patients.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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 27, 2024
Details:
Agamree (vamorolone),available now in US, is a novel drug candidate with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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, 2024
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the mineralcorticosteroid receptor and modifying its downstream activity, being developed for the treatment Duchenne muscular dystrophy in 2 yaers and older patients.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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:
Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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 15, 2024
Details:
Agamree (vamorolone) is a novel drug with a mode of action based on binding to the same receptor as glucocorticoids. It is approved for the treatment of duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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 12, 2024
Details:
Agamree (vamorolone) is a novel, small molecule glucocorticoid receptor agonist which is approved for the treatment of patients with Duchenne Muscular Dystrophy (DMD).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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 18, 2023
Details:
Agamree (vamorolone) is a novel drug candidate candidate, which binds to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug. Vamorolone is being indicated for DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Catalyst Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2023
Details:
Agamree (vamorolone) is a novel drug candidate with a mode of action based on binding to the same receptor as glucocorticoids but modifying its downstream activity, being developed for the treatment Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Agamree
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 13, 2023
Details:
Under the agreement, Catalyst gains commercialization rights in North America for VBP15 (vamorolone), an investigational drug candidate with a mode of action based on binding to the same receptor as glucocorticoids, in Duchenne muscular dystrophy (DMD).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Catalyst Pharmaceuticals
Deal Size: $231.0 million Upfront Cash: $75.0 million
Deal Type: Licensing Agreement July 19, 2023
Details:
Santhera will grant Catalyst exclusive commercialization rights to VBP15, an orally active dissociative steroidal anti-inflammatory agent, in North America and Santhera will continue to focus on European commercialization of vamorolone in duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Catalyst Pharmaceuticals
Deal Size: $231.0 million Upfront Cash: $90.0 million
Deal Type: Licensing Agreement June 20, 2023
Details:
VBP15 (vamorolone) is an investigational drug candidate, which binds to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug. Vamorolone is being developed for DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
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 April 25, 2023
Details:
VBP15 (vamorolone) it is an antagonist of the mineralocorticoid receptor, inactivating it. Studies in DMD patients have shown that mineralocorticoid receptor antagonists aid in preserving heart function in DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
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 02, 2023
Details:
The net funding will be used to support the Company through FDA decision on VBP15 (vamorolone), a dissociative steroid with novel mode of action, in Duchenne muscular dystrophy (DMD).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Highbridge Capital Management
Deal Size: $23.5 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 28, 2023
Details:
VBP15 (vamorolone) is an investigational drug candidate, which binds to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug. Vamorolone is being developed for DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
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 January 09, 2023
Details:
VBP15 (vamorolone) is an investigational drug candidate with a mode of action based on binding to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Santhera Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 27, 2022
Details:
Vamorolone is an investigational drug candidate with a mode of action based on binding to the same receptor as corticosteroids but modifying its downstream activity and as such is considered a dissociative anti-inflammatory drug.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 10, 2022
Details:
VBP15 (vamorolone) met its primary endpoint by demonstrating statistically significant and clinically relevant improvement in time to stand from floor compared to placebo, the first functional milestone to deteriorate in young children with DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
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, 2022
Details:
VBP15 (vamorolone) is a drug candidate with a mode of action that binds to the same receptor as corticosteroids but modifies its downstream activity and as such is considered a dissociative anti-inflammatory drug.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 22, 2022
Details:
Trial met primary endpoint demonstrating statistically significant and clinically meaningful reductions across all doses (63% at the 27mg QW dose; p<0.001) in triglycerides (TG) from baseline; results were consistent in patients on or not on background therapy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
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, 2022
Details:
VBP15 (Vamorolone) is a drug candidate with a novel mode of action that binds to the same receptor as corticosteroids but modifies its downstream activity and as such is a dissociative agonist.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 09, 2022
Details:
The trial met its primary endpoint of superiority in change of time to stand from supine position (TTSTAND) velocity with vamorolone, a dissociative agonist 6 mg/kg/day versus placebo (p=0.002) at 24 weeks (period 1).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 29, 2022
Details:
Evidence of clinical efficacy and safety of vamorolone in patients with DMD is based on the positive outcome of the pivotal Phase 2b VISION-DMD study and additional Phase 2a data covering a vamorolone treatment period of up to 30 months.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 15, 2022
Details:
Under the terms of the agreement, Santhera will grant Sperogenix Therapeutics exclusive development and commercialization rights to vamorolone in DMD and all other rare disease indications for Greater China (including mainland China, Hong Kong, Macau, and Taiwan).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Sperogenix Therapeutics
Deal Size: $124.0 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 04, 2022
Details:
Vamorolone could prove to be a promising alternative to the existing corticosteroids that are currently the standard of care for children and adolescents with DMD.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2021
Details:
Vamorolone is a first-in-class dissociative steroid which retains the anti-inflammatory activity of corticosteroids while decreasing the deleterious side effects used against Duchenne muscular dystrophy.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 23, 2021
Details:
In this trial, vamorolone demonstrated efficacy versus placebo over a three-fold dose range of 2 to 6 mg/kg/day versus placebo (p=0.002) and showed for both doses a favorable safety and tolerability profile versus the active control arm of prednisone 0.75mg/kg/day.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2021
Details:
The study met its primary endpoint of superiority in change of time to stand from supine positioning to standing (TTSTAND) velocity with vamorolone 6mg/kg/day, versus placebo.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2021
Details:
The two-year SBIR/STTR Commercialization Readiness Pilot (CRP) Program award will provide additional funding towards the new drug application preparation, enabling timely filing after the read-out of the fully-enrolled registration study (VBP15-004) anticipated in Q2 2021.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: National Institutes of Health
Deal Size: $3.3 million Upfront Cash: Undisclosed
Deal Type: Funding November 17, 2020
Details:
Vamorolone, the only dissociative steroid in development, is currently in a pivotal Phase 2b study in DMD patients with a 6-month readout expected in the second quarter of 2021.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Highbridge Capital Management
Deal Size: $16.5 million Upfront Cash: Undisclosed
Deal Type: Financing November 02, 2020
Details:
Data further show that vamorolone uniformly weakens co-activator associations, which leads to loss of gene transcriptional activities associated with safety concerns of corticosteroids.
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: ReveraGen BioPharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2020
Details:
Santhera has obtained an exclusive license from ReveraGen, the originator of vamorolone, for all indications worldwide. Vamorolone is currently being investigated in the pivotal Phase 2b VISION-DMD study in patients with Duchenne muscular dystrophy (DMD).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: VBP15
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Santhera Pharmaceuticals
Deal Size: $11.4 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 02, 2020
Details:
Data from this VBP15-003 study in comparison to natural history study data demonstrated dose-dependent improvement in timed function tests. Vamorolone was reported to be safe and well tolerated up to the highest dose tested (6.0 mg/kg/day).
Lead Product(s): Vamorolone
Therapeutic Area: Genetic Disease Product Name: Undisclosed
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 02, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
