Recent Updates
Recently added Catalysts

Olatorepatide

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Oct 13, 2026

Olatorepatide development status

Highest phase Phase 2
Registered trials 4 across 2 sponsors since Nov 2023

Olatorepatide target and mechanism

Molecular targetMC4R
Target class-Tide (Peptide)
ModalitySmall molecule

Also known as HS-20094

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment780

FDA Designations

No designations recorded

Olatorepatide clinical trials

Olatorepatide · 3 trials · 2 indications

Phase 2 3
NCT07830329Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or ObesityHidradenitis Suppurativa
NOT YET_RECRUITING300 Analytics
NCT07685808Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without DiabetesOverweight or Obesity
RECRUITING360 Analytics
NCT07431086Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the USOverweight or Obesity
ACTIVE NOT_RECRUITING120 Analytics
PHASE2NOT YET_RECRUITING
Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity
Hidradenitis SuppurativaUnlock trial analytics
PHASE2RECRUITING
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes
Overweight or ObesityUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Olatorepatide in Adult Participants Living With Overweight or Obesity in the US
Overweight or ObesityUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in total Abscess and inflammatory Nodule (AN) count
From baseline to week 52
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Up to approximately 60 weeks
Severity of TEAEs
Up to approximately 60 weeks
Percent change in body weight
From baseline to week 52
Maximum plasma Concentration (Cmax)
At week 15 and week 24
Area Under the Concentration time curve from time 0 to 168 hours (AUC0-168h)
At week 15 and week 24

Secondary Endpoints

Percent change in body weight
From baseline to week 52
Achieving HiSCR50 (≥50% reduction from baseline in total AN counts with no increase in abscess count and no increase in draining tunnel count)
At week 52
Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)
From baseline to week 52
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OlatorepatideEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Olatorepatide arm 1EXPERIMENTAL -
Olatorepatide arm 2EXPERIMENTAL -
Olatorepatide arm 3EXPERIMENTAL -
Olatorepatide arm 4EXPERIMENTAL -
Olatorepatide arm 5EXPERIMENTAL -
Matching Placebo arm 6ACTIVE_COMPARATOR -
General CohortEXPERIMENTAL -
Subgroup CohortEXPERIMENTAL -

Interventions

NameTypeDescription
OlatorepatideDRUGAdministered per the protocol
PlaceboDRUGAdministered per the protocol
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: 1. Diagnosis of HS based on: 1. Documented or reported history of HS for ≥6 months prior to baseline visit 2. Confirmation of HS by the investigator during physical examination at screening 2. HS lesions present in at least 2 distinct anatomic areas as described in th...

Countries:United States
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWOct 13, 2026NCT07685808lastUpdatePostDate: changed
LOWOct 13, 2026NCT07685808lastUpdatePostDate: changed
LOWSep 29, 2026NCT07685808lastUpdatePostDate: changed
LOWSep 29, 2026NCT07685808lastUpdatePostDate: changed
LOWSep 21, 2026NCT07830329NEW_TRIAL: changed
LOWSep 21, 2026NCT07830329NEW_TRIAL: changed
LOWAug 20, 2026NCT07685808Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07685808Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about Olatorepatide

What is Olatorepatide?

Olatorepatide is an investigational small molecule being developed by Regeneron Pharmaceuticals, Inc. (ticker: REGN) for hidradenitis suppurativa and for overweight or obesity. It is currently in Phase 2 clinical development and has not been approved by the FDA. It is designed to target MC4R.

What is Olatorepatide used for?

Olatorepatide is being studied for two indications: moderate to severe hidradenitis suppurativa in adults living with overweight or obesity, and overweight or obesity in adults without diabetes. Both uses remain investigational, as the drug is in Phase 2 testing and has not received FDA approval for any indication.

What does Olatorepatide target?

Olatorepatide targets MC4R, the melanocortin 4 receptor. MC4R is a G protein-coupled receptor involved in energy balance and appetite regulation, making it a relevant pathway for weight-related conditions. Olatorepatide is a small molecule in the peptide-like class, and its activity at MC4R is the basis for its study in overweight or obesity and hidradenitis suppurativa.

Who makes Olatorepatide?

Olatorepatide is being developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. Regeneron is the sponsor of the Phase 2 clinical program evaluating the drug in hidradenitis suppurativa and in overweight or obesity.

What phase is Olatorepatide in?

Olatorepatide is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two active Phase 2 trials are underway, and no completed trials have been reported. The program includes randomized, double-blind, placebo-controlled studies, with total planned enrollment of about 480 participants across the trials.

What clinical trials is Olatorepatide in?

Olatorepatide is being evaluated in Phase 2 trials including NCT07830329 in moderate to severe hidradenitis suppurativa with overweight or obesity, NCT07685808 in overweight or obesity without diabetes in the United States, and NCT07431086 in overweight or obesity in the United States. These studies are randomized, double-blind, and placebo-controlled, enrolling adults aged 18 years and older.