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JP-1366

Phase 3

Erosive Esophagitis | Small molecule | Gastrointestinal |cbdMD, Inc.|Last Updated: Nov 1, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment300

FDA Designations

No designations recorded

Clinical trial landscape

JP-1366 · 2 trials · 2 indications

Phase 3 2
NCT06439563Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic UlcersPeptic Ulcer
RECRUITING364 Analytics
NCT05443984JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive EsophagitisErosive Esophagitis
COMPLETED300 Analytics
PHASE3RECRUITING
Study to Evaluate the Efficacy and Safety of JP-1366 in the Prevention of NSAIDs-Induced Peptic Ulcers
Peptic UlcerUnlock trial analytics
PHASE3COMPLETED
JP-1366 20mg Versus Esomeprazole 40mg in Patients With Erosive Esophagitis
Erosive EsophagitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Cumulative proportion of subjects who developed peptic ulcers
at 24 weeks after administration of investigational products
The cumulative healing rate of mucosal break at 8-week after the investigational product administration (%)
Week 8

The proportion of subjects with remission on endoscopy at 8-week

Secondary Endpoints

Proportion of subjects with gastric or duodenal endoscopic bleeding
at 24 weeks after administration of investigational products
Healing rate of mucosal break at the 4-week after the investigational product administration
Week 4
Healing rate of mucosal break evaluated by an independent evaluator at the 4-week after the investigational product administration
Week 4
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
JP-1366 10 mgEXPERIMENTAL -
Lanston Capsule 15 mgACTIVE_COMPARATOR -
Experimental GroupEXPERIMENTALJP-1366 20mg + Esomeprazole 40mg(placebo)
Active Comparative GroupACTIVE_COMPARATORJP-1366 20mg(placebo) + Esomeprazole 40mg

Interventions

NameTypeDescription
JP-1366 10 mgDRUGJP-1366 10 mg, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mgDRUGLanston Capsule 15 mg orally once a day for up to 24 weeks
JP-1366 10 mg placeboDRUGJP-1366 10 mg placebo, tablet, orally once a day for up to 24 weeks
Lanston Capsule 15 mg placeboDRUGLanston Capsule 15 mg placebo, orally once a day for up to 24 weeks
JP-1366 20mgDRUG1 capsule of JP-1366 20 mg, 1 tablet of esomeprazole placebo (irrespective of meals)
Esomeprazole 40mgDRUG1 capsule of JP-1366 placebo, 1 tablet of esomeprazole 40 mg placebo (irrespective of meals)
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Eligibility Criteria

Age Range19 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Adult male/female aged 19 years or older as of the date of obtaining consent 2. Those who are diagnosed with musculoskeletal diseases such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, or other diseases at the time of screening and require continuous admini...

Countries:South Korea
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Frequently asked questions about JP-1366

What is JP-1366 used for?

JP-1366 is an investigational small molecule being developed for erosive esophagitis and peptic ulcer, both gastrointestinal conditions. It is currently in Phase 3 clinical development and has not been approved by the FDA.

Who makes JP-1366?

JP-1366 is being developed by cbdMD, Inc., which trades under the ticker YCBD. The company is conducting Phase 3 trials for the drug in South Korea.

What phase is JP-1366 in?

JP-1366 is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 3 trials have been conducted or are ongoing, with one completed and one currently recruiting.

What clinical trials is JP-1366 in?

JP-1366 has two Phase 3 trials. NCT05443984 compared JP-1366 20mg to esomeprazole 40mg in erosive esophagitis and is completed. NCT06439563 is recruiting to evaluate JP-1366 in preventing NSAID-induced peptic ulcers. Both trials are in South Korea.

Is JP-1366 the same as JP-1366 10 mg?

JP-1366 is also known as JP-1366 10 mg. This alternative name refers to a specific dosage strength of the drug, which is being investigated in clinical trials for gastrointestinal conditions.