Last reviewed · How we verify
GLUCOPHAGE®XR
GLUCOPHAGE®XR is a Small molecule drug developed by IPCA Laboratories Ltd.. It is currently in Phase 1 development. Also known as: Reference product.
-
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 | GLUCOPHAGE®XR |
|---|---|
| Also known as | Reference product |
| Sponsor | IPCA Laboratories Ltd. |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg in Fast Condition (PHASE1)
- iSGLT2 Inhibitor and a iDPP -4 Inhibitor in Treatment of Type 2 Diabetes Mellitus in Patients Treated With Metformin (TRIAD) (PHASE3)
- Bioequivalence Study to Compare Empagliflozin / Metformin 25 mg/ 1000 mg Extended-Release Tablet Versus Synjardy XR Tablets 25mg/1000mg (PHASE1)
- Bioequivalence Study to Compare Empagliflozin/Linagliptin/Metformin HCL 25mg/5mg/1000mg Extended-Release Tablets Versus Trijardy® XR Extended Release Film Coated Tablets (PHASE1)
- TRIGLYTZA® VERSUS METFORMIN IN OBESE ADULT TYPE 2 DIABETES (T2DM) PATIENTS OVER 24 WEEKS OF TREATMENT (PHASE2)
- Metformin ER 750 mg Tablets, Fed (PHASE1)
- Metformin ER 750 mg Tablets, Fasting (PHASE1)
- Fasting Study of Metformin Hydrochloride ER Tablets 750 mg and Glucophage® XR Tablets 750 mg (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:
- GLUCOPHAGE®XR CI brief — competitive landscape report
- GLUCOPHAGE®XR updates RSS · CI watch RSS
- IPCA Laboratories Ltd. portfolio CI
Frequently asked questions about GLUCOPHAGE®XR
What is GLUCOPHAGE®XR?
Who makes GLUCOPHAGE®XR?
Is GLUCOPHAGE®XR also known as anything else?
What development phase is GLUCOPHAGE®XR in?
Related
- Manufacturer: IPCA Laboratories Ltd. — full pipeline
- Also known as: Reference product
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing