Metabolic profile

Monica Levy Andersen · Phase 1 active Biologic

Metabolic profile is a Biologic drug developed by Monica Levy Andersen. It is currently in Phase 1 development. Also known as: Glucose, Total cholesterol and fractions, Triglycerides, Uric acid.

Metabolic profile is studied in relation to various conditions including overweight and obesity, exertion, oxygen toxicity, sarcopenia, and diabetes mellitus. The metabolic profile is investigated through interventions such as the ketogenic diet and the small molecule pitolisant, which is used to study its effects on muscle metabolism and inflammatory status.

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	Metabolic profile
Also known as	Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine
Sponsor	Monica Levy Andersen
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Screening and Multiple Intervention on Lung Epidemics (PHASE2)
• The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease (NA)
• Tritordeum-based Foods for IBS Symptoms (NA)
• Gut Microbiome-Metabolome Profiling in H. Pylori-SIBO Comorbidity
• SHAPE-ENDO: Multimodal Pre-Surgical Optimization in Patients With Obesity and Early-Stage Endometrial Cancer
• Pro- and Anti-inflammatory Cytokines in PCOS
• Adipokines in Polycystic Ovary Syndrome
• The Role of CYP8B1 Polymorphisms in Modulating the Biochemical Pathways Affected by SGLT2 Inhibitors in T2DM and Obesity (PHASE4)

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:

• Metabolic profile CI brief — competitive landscape report
• Metabolic profile updates RSS · CI watch RSS
• Monica Levy Andersen portfolio CI

Frequently asked questions about Metabolic profile

What is Metabolic profile?

Metabolic profile is a Biologic drug developed by Monica Levy Andersen.

Who makes Metabolic profile?

Metabolic profile is developed by Monica Levy Andersen (see full Monica Levy Andersen pipeline at /company/monica-levy-andersen).

Is Metabolic profile also known as anything else?

Metabolic profile is also known as Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine.

What development phase is Metabolic profile in?

Metabolic profile is in Phase 1.

Related

• Manufacturer: Monica Levy Andersen — full pipeline
• Also known as: Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine