Cystadane
(Betaine)Phase 2Small molecule
Cystadane is one of 40 small molecule programs targeting Angelman syndrome. It is currently in Phase 2.
3
Indications
10
Total Trials
2
Active Trials
39
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[3][1]
Competition
Competitive Landscape
43 competitors in Hepatitis
#DrugCompanyPhaseTrials
1Medrol
PfizerApproved
Sovaldi
GileadApproved
Tyzeka
NovartisApproved
Viread
GileadApproved
Glucophage
EMD SeronoApproved
Singulair
OOrganon and Co
Approved
Baraclude
KKaruna Therapeutics, Inc., a Bristol Myers Squibb company
Approved
Epivir
GGlaxo Dba Glaxosmithkline
Approved
Deltasone
PPfizer's Upjohn has merged with Mylan to form Viatris Inc.
Phase 3
Cellcept
RochePhase 2
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Chronic Hepatitis2 trials
Primary Hyperoxaluria1 trial
Adult1 trial
A Preliminary Study of Choline and Betaine Supplementation Among Adults Exposed to Arsenic in Bangladesh
Completed·—·Phase 4·NCT01749982·60 enrolled
4 more indications
Hepatitis1 trial
Betaine vs. Placebo for Serologically Diagnosed Metabolic Dysfunction-associated Steatohepatitis (MASH)
Not yet recruiting·SSouthern California Institute for Research and Education·Phase 2·NCT07276204·70 enrolled
Peroxisome Biogenesis Disorders1 trial
Betaine and Peroxisome Biogenesis Disorders
Completed·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT01838941·12 enrolled
Regulatory
FDA Approval Timeline[4]
Oct 25, 1996
CYSTADANE
NDA NDA020576
Sources
References
- [1]
- [2]
- [3]Open Targets Platform — Drug–disease associations for Betaine. EMBL-EBI & Wellcome Sanger Institute.
- [4]
- [5]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[2]
- Highest Phase
- Phase 2[1]
- Company
- RRECORDATI GROUP