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aleglitazar+metformin
aleglitazar+metformin is a PPARα/γ agonist and biguanide Small molecule drug developed by Hoffmann-La Roche. It is currently in Phase 3 development for Type 2 diabetes.
Aleglitazar, a PPARα/γ agonist, and metformin, a biguanide, work together to improve insulin sensitivity and glucose uptake in the body.
Aleglitazar, a peroxisome proliferator-activated receptor alpha agonist, was studied in combination with metformin for the treatment of type 2 diabetes mellitus. The combination of aleglitazar and metformin was compared to a placebo and aleglitazar alone in a randomized, double-blind, placebo-controlled clinical trial.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Hoffmann-La Roche is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | aleglitazar+metformin |
|---|---|
| Sponsor | Hoffmann-La Roche |
| Drug class | PPARα/γ agonist and biguanide |
| Target | PPARα, PPARγ |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
Aleglitazar activates PPARα and PPARγ receptors, enhancing the transcription of genes involved in glucose and lipid metabolism. Metformin inhibits hepatic glucose production and increases insulin sensitivity in peripheral tissues.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Diarrhea
- Abdominal pain
- Headache
- Fatigue
Key clinical trials
- A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Alone (PHASE3)
- A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin Monotherapy (PHASE3)
- A Study to Evaluate the Effect of Aleglitazar on Cardiac Energetics and Function in Patients With Type 2 Diabetes Mellitus and no History of Coronary Artery Disease (PHASE2)
- A Study of Aleglitazar in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Sulfonylurea Alone or Sulfonylurea Plus Metformin Therapy (PHASE3)
- A Study of The Effect of Aleglitazar on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Controlled With Metformin (PHASE2)
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:
- aleglitazar+metformin CI brief — competitive landscape report
- aleglitazar+metformin updates RSS · CI watch RSS
- Hoffmann-La Roche portfolio CI
Frequently asked questions about aleglitazar+metformin
What is aleglitazar+metformin?
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What is aleglitazar+metformin used for?
Who makes aleglitazar+metformin?
What drug class is aleglitazar+metformin in?
What development phase is aleglitazar+metformin in?
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What does aleglitazar+metformin target?
Related
- Drug class: All PPARα/γ agonist and biguanide drugs
- Target: All drugs targeting PPARα, PPARγ
- Manufacturer: Hoffmann-La Roche — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing