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RG1068

Phase 3

Autism | Small molecule | Psychiatry |Repligen Corporation|Last Updated: Feb 23, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment -

FDA Designations

No designations recorded

Clinical trial landscape

RG1068 · 3 trials · 3 indications

Phase 3 2Phase 2 1
NCT00660335Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the PancreasPancreatitis
COMPLETED258 Analytics
NCT00036244Synthetic Human Secretin in Children With AutismAutism
COMPLETED- Analytics
PHASE3COMPLETED
Safety and Efficacy of Synthetic Human Secretin-Enhanced MRCP in Subjects With Abnormalities of the Pancreas
PancreatitisUnlock trial analytics
PHASE3COMPLETED
Synthetic Human Secretin in Children With Autism
AutismUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary outcome measure will be assessed by comparing baseline MRCP images and RG1068-enhanced MRCP images for the presence or absence of pancreatic abnormalities.
0 - 10 minutes post dose
Change in Yale-Brown Obsessive Compulsive Scale and
Clinical Global Impression of Change Scale

Secondary Endpoints

The secondary outcome measure will assess safety
up to 30 days
Change in Hamilton Anxiety Scale,
Montgomery-Asberg Depressing Rating Scale, and
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
Currently treated with SSRIEXPERIMENTAL -
Not currently treated with SSRIEXPERIMENTAL -

Interventions

NameTypeDescription
RG1068 (synthetic human secretin)DRUGSingle-dose, IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * History of pancreatitis * Medically stable * Able to give informed consent Exclusion Criteria: * Prior history of pancreatic resection * Prior history of pancreatic duct drainage procedure * Presence of a pancreatic stent * Unstable cardiovascular disease * Any contraindicat...

Countries:United States
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Frequently asked questions about RG1068

What is RG1068 used for?

RG1068 is an investigational synthetic human secretin being studied for use in autism, pancreatitis, and obsessive compulsive disorder (OCD). It is a small molecule developed by Repligen Corporation. Clinical trials have evaluated it in children with autism, in patients with OCD, and in subjects with pancreatic abnormalities.

Who makes RG1068?

RG1068 is being developed by Repligen Corporation, a biopharmaceutical company traded on NASDAQ under the ticker RGEN. The company has sponsored clinical trials of RG1068 in the United States across multiple indications.

What phase is RG1068 in?

RG1068 has completed Phase 3 clinical trials for autism and pancreatitis, and a Phase 2 trial for obsessive compulsive disorder. All trials are completed, and the drug remains investigational, meaning it is not yet approved by regulatory authorities.

What clinical trials is RG1068 in?

RG1068 has been studied in three completed trials: NCT00036244, a Phase 3 study in children with autism; NCT00216294, a Phase 2 safety study in patients with OCD; and NCT00660335, a Phase 3 safety and efficacy study in subjects with pancreatic abnormalities.

Is RG1068 the same as secretin?

RG1068 is a synthetic form of human secretin, a naturally occurring hormone. It is being investigated as a therapeutic agent for conditions such as autism and pancreatitis, and as a diagnostic enhancer for magnetic resonance cholangiopancreatography (MRCP) in pancreatic disease.