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Otic neural progenitors

Phase 1

Sensorineural Hearing Loss | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

Otic neural progenitors · 1 trial · 3 indications

Phase 1 1
NCT07032038First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear ImplantSensorineural Hearing Loss
NOT YET_RECRUITING20 Analytics
PHASE1NOT YET_RECRUITING
First In Human Randomised Trial of Rincell-1 in Adults With a Cochlear Implant
Sensorineural Hearing LossUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency and severity of AEs
From baseline (at screening) to 52 weeks post-implantation

Frequency and severity of AEs considered related to Rincell-1 alone, the procedure used to administer Rincell-1, and to the CI device and/or the administered concomitant NIMP regime.

Secondary Endpoints

Changes in mean ECAP thresholds
From post-implantation baseline to 40 weeks post-implantation
Feasibility of administration of Rincell-1
At time of administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Standard Care Unilateral CI + Rincell-1EXPERIMENTALRoutine unilateral cochlear implantation with simultaneous single dose of Rincell-1
Standard Care Unilateral CI onlyACTIVE_COMPARATORRoutine unilateral cochlear implantation only

Interventions

NameTypeDescription
Otic neural progenitorsDRUGAdvanced Cell Therapy - tissue engineered product
cochlear implantationDEVICEcochlear implant
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Eligibility Criteria

Age Range18 Years to 74 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: Cohort 1 Only 1. Aged 60-74 years (inclusive) at time of consent 2. Hearing Loss due to bilateral progressive presbycusis 3. Approved for unilateral cochlear implantation as per UK NICE criteria (TA566) 4. Documented threshold of ≥70dB in both ears at 1000, 2000 and 4000 Hz, an...

Countries:United Kingdom
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Frequently asked questions about Otic neural progenitors

What is Otic neural progenitors used for?

Otic neural progenitors, also known as Rincell-1, is an investigational small molecule being developed for sensorineural hearing loss. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does Otic neural progenitors target?

Otic neural progenitors, or Rincell-1, is a small molecule designed to address sensorineural hearing loss. The specific molecular target has not been disclosed, but the therapy is being studied in patients with cochlear implants to evaluate its potential to restore or improve auditory function.

Who makes Otic neural progenitors?

Otic neural progenitors, also known as Rincell-1, is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting a Phase 1 clinical trial to evaluate the therapy in adults with cochlear implants.

What phase is Otic neural progenitors in?

Otic neural progenitors, or Rincell-1, is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The ongoing Phase 1 trial is a first-in-human study designed to assess the safety and preliminary efficacy of the treatment.

What clinical trials is Otic neural progenitors in?

Otic neural progenitors, or Rincell-1, is being evaluated in a Phase 1 clinical trial registered as NCT07032038. This first-in-human, randomized, active-controlled study is enrolling 20 adults with cochlear implants in the United Kingdom, with conditions including sensorineural hearing loss, presbyacusis, and auditory neuropathy.

Is Otic neural progenitors the same as Rincell-1?

Yes, Otic neural progenitors is also known as Rincell-1. The therapy is being developed under this alternative name in clinical trial records, including the Phase 1 study NCT07032038, which evaluates Rincell-1 in adults with cochlear implants.