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Metabolic profile
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.
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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).
| 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
Common side effects
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?
Who makes Metabolic profile?
Is Metabolic profile also known as anything else?
What development phase is Metabolic profile in?
Related
- Manufacturer: Monica Levy Andersen — full pipeline
- Also known as: Glucose, Total cholesterol and fractions, Triglycerides, Uric acid, Creatinine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing