Thought I should provide a little updated summary of which drugs currently are in the Pipeline for IBS-C, concerning only 505B1&505B2 filings at the FDA or corresponding agencies. Drugs mentioned above which are being investigated for chronic constipation, obstruction etc. are also included in the list but they would have to be used off-label. You can find information about ongoing trials below the Pipeline.
If you're aware of any other drugs under development please comment below. (Can't create a table in this forum so excuse the less beautiful columns)
Pipeline:
Name/ dev.Code----------
Company--------------------------
Mechanism of Action ---------------------------------
IBS sub-type----------------------------
Status------------------------
Ongoing Trial--
Olorinab----------------
Arena Pharmaceuticals--------------CB2 agonist---------------------------------------------------IBS-Pain----------------------------Phase 2B ongoing--------------
NCT04043455----
Tenapanor-------------
Ardelyx-----------------------------------NHE3 Inhibitor------------------------------------------------IBS-C--------------------------------FDA Approved as IBSRELA
SYN-010---------------
Synthetic Biologics--------------------HMG-CoA reductase inhibitors--------------------------IBS-C---------------------------------Phase 2 ongoing----------------
NCT03763175
Naronapride-----------
Renexxion-------------------------------5-HT4 agonist------------------------------------------------IBS-C---------------------------------Phase 2
Blautix------------------
4D Pharma PLC-----------------------Gastrointestinal microbiome modulators---------------IBS-Pain----------------------------Phase 2----------------------------
NCT03721107
TD-8954---------------
Theravance Biopharma--------------5-HT4 agonist-------------------------------------------------Motility disorders------------------Phase 2
RQ-00000010--------
RaQualia---------------------------------5HT-4 agonist-------------------------------------------------Motility disorders------------------Phase 1
Drugs in ongoing trials
Olorinab (APD371), is a painkiller for all IBS sub-types (78% of patients suffer from abdominal pain). It is currently under development by
Arena Pharmaceuticals and has now entered into another Phase 2 Clinical Trial
(NCT04043455). Olorinab lessens pain by targeting the Cannabinoid Type 2 Receptor (CB2). The compound is peripherally acting and highly selective which means it lacks psychotropic effect (it doesn't make you high), which is quite important when targeting the Cannabinoid system. Last year Arena published results of an exploratory
Phase 2a safety and efficacy trial, which showed a good safety profile and an average pain reduction of 82% in patients with Crohn's Disease in remission, suffering the same type of pain IBS patients do.
To participate in the Phase 2 study,
click here to get further information from Arena or give them a call if you're in the US at 855-634-0290.
SYN-010 is a reformulation of the already approved drug Lovastatin, which is intended to reduce methane-production by certain microorganisms (M. smithii) to combat bloating, pain and constipation in patients with IBS-C. By using a delayed release formula it's designed to act primarily in the intestinal lumen while avoiding systemic absorption and thus enhancing its efficacy. SYN-010 is being developed by
Synthetic Biologics and is currently in Phase 2 clinical trials
(NCT03763175).
To participate in the Phase 2 study,
click here to contact Synthetic Biologics.
Blautix is a single-strain human gut commensal bacteria which is being investigated for the treatment of IBS. By its distinct metabolism Blautix consumes gases which are known to cause bloating, abdominal pain and changes in bowel frequency.
4D Pharma is currently conducting a Phase 2 clinical trial
(NCT03721107) to see if Blautix is effective in both IBS-C and IBS-D patients.
To participate in the Phase 2 study,
click here to get more information.
