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RG1068

Phase 3

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

RG1068 target and mechanism

ModalitySmall molecule

Also known as RG1068 (Synthetic Human Secretin)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials3
Total Enrollment270

FDA Designations

No designations recorded

RG1068 clinical trials

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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Competitive Landscape -Autism Spectrum Disorder 23 trials (matched to "Autism")

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Frequently asked questions about RG1068

What is RG1068?

RG1068 is a synthetic human secretin developed by Repligen Corporation. It has been studied in pancreatitis imaging and in psychiatric and neurodevelopmental conditions including autism and obsessive compulsive disorder. The program's lead Phase 3 trial evaluated synthetic human secretin-enhanced MRCP in patients with abnormalities of the pancreas.

What is RG1068 used for?

RG1068 has been studied for imaging of the pancreas in patients with pancreatitis, and separately in autism and obsessive compulsive disorder. Its most advanced evaluation is a completed Phase 3 trial of synthetic human secretin-enhanced MRCP in subjects with abnormalities of the pancreas, which enrolled 258 participants.

Who makes RG1068?

RG1068 is developed by Repligen Corporation, which trades on the Nasdaq under the ticker RGEN. Repligen sponsored the clinical program for synthetic human secretin across pancreatic imaging, autism, and obsessive compulsive disorder indications.

What phase is RG1068 in?

RG1068 has reached Phase 3. A Phase 3 trial of synthetic human secretin-enhanced MRCP in patients with pancreatic abnormalities has been completed, and a Phase 3 study of synthetic human secretin in children with autism has also been completed. No trials are currently listed as active.

What clinical trials is RG1068 in?

RG1068 has been studied in completed trials including NCT00660335, a Phase 3 trial of synthetic human secretin-enhanced MRCP in pancreatitis that enrolled 258 subjects, NCT00216294, a Phase 2 safety study in obsessive compulsive disorder, and NCT00036244, a Phase 3 study of synthetic human secretin in children with autism.

Is RG1068 the same as synthetic human secretin?

Yes. RG1068 is also known as synthetic human secretin, and the two names refer to the same investigational agent. Repligen Corporation developed RG1068 under both designations, and its trials are listed under the synthetic human secretin name in registry records.