Last reviewed 2026-04-20 · How we verify

Ketone supplementation

Vanderbilt University Medical Center · Phase 1 active Small molecule Quality 3/100

Ketone supplementation is a Small molecule drug developed by Vanderbilt University Medical Center. It is currently in Phase 1 development. Also known as: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester, D-BHB monoester, ketone monoester.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Ketone supplementation
Also known as	(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester, D-BHB monoester, ketone monoester, (R)-hydroxybutyl (R)-3-hydroxybutyrate;
Sponsor	Vanderbilt University Medical Center
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Short Term Ketone Supplementation and Cardiometabolic Health (NA)
Effects of Ketone Supplement and Alcohol on Brain Metabolism (PHASE2, PHASE3)
Ketones for Opioid Craving (PHASE2)
BHB & CAR-T for Lymphomas (NA)
Exogenous Ketone Supplementation in ICU Delirium (PHASE1)
Effects of Ketone Bodies on Insulin Sensitivity (NA)
Acute and Chronic Effects of Oral Ketones in Subjects With HFrEF and Diabetes (EARLY_PHASE1)
Acute Effects of Ketone Supplement on Responses to Alcohol Challenge in Healthy Volunteers (PHASE2, PHASE3)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Ketone supplementation CI brief — competitive landscape report
Ketone supplementation updates RSS · CI watch RSS
Vanderbilt University Medical Center portfolio CI

Frequently asked questions about Ketone supplementation

What is Ketone supplementation?

Ketone supplementation is a Small molecule drug developed by Vanderbilt University Medical Center.

Who makes Ketone supplementation?

Ketone supplementation is developed by Vanderbilt University Medical Center (see full Vanderbilt University Medical Center pipeline at /company/vanderbilt-university-medical-center).

Is Ketone supplementation also known as anything else?

Ketone supplementation is also known as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester, D-BHB monoester, ketone monoester, (R)-hydroxybutyl (R)-3-hydroxybutyrate;.

What development phase is Ketone supplementation in?

Ketone supplementation is in Phase 1.

Manufacturer: Vanderbilt University Medical Center — full pipeline
Also known as: (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, D-β-hydroxybutyrate monoester, D-BHB monoester, ketone monoester, (R)-hydroxybutyl (R)-3-hydroxybutyrate;

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing