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Comparator: Rosiglitazone
Comparator: Rosiglitazone is a Thiazolidinedione Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for Type 2 diabetes mellitus. Also known as: Avandia.
Rosiglitazone is a thiazolidinedione that activates peroxisome proliferator-activated receptor gamma (PPAR-γ) to improve insulin sensitivity and reduce blood glucose levels.
Rosiglitazone is a small molecule that acts as a peroxisome proliferator-activated receptor gamma agonist. It is used to treat conditions such as Type 2 Diabetes Mellitus and Cardiovascular Diseases, among others, as a comparator in clinical trials.
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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
Merck Sharp & Dohme LLC 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 | Comparator: Rosiglitazone |
|---|---|
| Also known as | Avandia |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Thiazolidinedione |
| Target | PPAR-γ (Peroxisome proliferator-activated receptor gamma) |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
By binding to PPAR-γ in adipose tissue and muscle, rosiglitazone enhances insulin signaling and glucose uptake, reducing hepatic glucose production and improving peripheral insulin sensitivity. This mechanism addresses the underlying insulin resistance in type 2 diabetes rather than stimulating insulin secretion directly.
Approved indications
- Type 2 diabetes mellitus
Common side effects
- Weight gain
- Fluid retention / edema
- Hypoglycemia (when combined with other agents)
- Headache
- Upper respiratory tract infection
Key clinical trials
- A Study for Comparison of Canagliflozin Versus Alternative Antihyperglycemic Treatments on Risk of Heart Failure Hospitalization and Amputation for Participants With Type 2 Diabetes Mellitus and the Subpopulation With Established Cardiovascular Disease
- Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128) (PHASE3)
- Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052) (PHASE3)
- Thiazolidinedione Intervention With Vitamin D Evaluation (PHASE4)
- Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801) (PHASE3)
- QTc Study of Rosi XR in Healthy Volunteers (PHASE1)
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:
- Comparator: Rosiglitazone CI brief — competitive landscape report
- Comparator: Rosiglitazone updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: Rosiglitazone
What is Comparator: Rosiglitazone?
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Is Comparator: Rosiglitazone also known as anything else?
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Related
- Drug class: All Thiazolidinedione drugs
- Target: All drugs targeting PPAR-γ (Peroxisome proliferator-activated receptor gamma)
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes mellitus
- Also known as: Avandia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing