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Olbetam
Olbetam is a Small molecule drug developed by University of Aarhus. It is currently in Phase 1 development for Hyperlipoproteinemia.
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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 | Olbetam |
|---|---|
| Sponsor | University of Aarhus |
| Target | Hydroxycarboxylic acid receptor 2 |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
- Hyperlipoproteinemia
Common side effects
- Nausea and vomiting
Key clinical trials
- Ketones, SGLT2, HFrEF (EARLY_PHASE1)
- Co-Feedback Action of Growth Hormone, PP and PYY on Ghrelin in Bulimia (PHASE2)
- Forearm Immobilization, Metabolic Health, and Muscle Loss (NA)
- Glucose and Glycogen Dynamics in Prediabetes
- Can Brisk Walking Combined With Ingestion of a Lipid-lowering Drug Improve Fat Metabolism in Muscle? (NA)
- Can the Health Benefits of a Walking-based Exercise Programme be Enhanced by Co-ingestion of a Lipid-lowering Drug? (NA)
- The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome (PHASE2, PHASE3)
- Effects of Acipimox on Insulin Action, Vascular Function, and Muscle Function in Type 1 Diabetes (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:
- Olbetam CI brief — competitive landscape report
- Olbetam updates RSS · CI watch RSS
- University of Aarhus portfolio CI
Frequently asked questions about Olbetam
What is Olbetam?
What is Olbetam used for?
Who makes Olbetam?
What development phase is Olbetam in?
What are the side effects of Olbetam?
What does Olbetam target?
Related
- Target: All drugs targeting Hydroxycarboxylic acid receptor 2
- Manufacturer: University of Aarhus — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Hyperlipoproteinemia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing