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Metformin plus Yasmin
Metformin plus Yasmin is a Combination therapy: biguanide antidiabetic agent + oral contraceptive Small molecule drug developed by Catholic University of the Sacred Heart. It is currently in Phase 3 development for Type 2 diabetes or prediabetes in women requiring contraception, Polycystic ovary syndrome (PCOS) with metabolic dysfunction.
This combination pairs metformin, which reduces hepatic glucose production and improves insulin sensitivity, with Yasmin (drospirenone/ethinyl estradiol), a hormonal contraceptive, to address both glycemic control and contraceptive needs in women with diabetes or prediabetes.
This combination pairs metformin, which reduces hepatic glucose production and improves insulin sensitivity, with Yasmin (drospirenone/ethinyl estradiol), a hormonal contraceptive, to address both glycemic control and contraceptive needs in women with diabetes or prediabetes. Used for Type 2 diabetes or prediabetes in women requiring contraception, Polycystic ovary syndrome (PCOS) with metabolic dysfunction.
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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).
| 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 | Metformin plus Yasmin |
|---|---|
| Sponsor | Catholic University of the Sacred Heart |
| Drug class | Combination therapy: biguanide antidiabetic agent + oral contraceptive |
| Target | Metformin: AMP-activated protein kinase (AMPK) pathway; Yasmin: progesterone receptor and estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Contraception |
| Phase | Phase 3 |
Mechanism of action
Metformin acts as a biguanide that decreases gluconeogenesis in the liver and enhances peripheral insulin sensitivity, thereby lowering blood glucose levels. Yasmin is an oral contraceptive containing a progestin (drospirenone) and estrogen (ethinyl estradiol) that prevents ovulation. The combination allows simultaneous management of metabolic dysfunction and pregnancy prevention in women requiring both interventions.
Approved indications
- Type 2 diabetes or prediabetes in women requiring contraception
- Polycystic ovary syndrome (PCOS) with metabolic dysfunction
Common side effects
- Gastrointestinal disturbance (metformin)
- Nausea
- Headache (hormonal component)
- Breast tenderness
- Lactic acidosis (metformin, rare)
Key clinical trials
- Research on Risk Factors and Interventions of Polycystic Ovary Syndrome Complicated With Depression and Anxiety (NA)
- Impact of Metformin in Teens With Polycystic Ovary Syndrome (PCOS) on Oral Contraceptive Therapy (PHASE3)
- Effects of Drospirenone-ethinylestradiol and/or Metformin on Cardiovascular Risk in Hyperinsulinemic Women With Polycystic Ovary Syndrome (PHASE3)
- Metformin+ Drospirenone/ethinylestradiol30µg and Flow-mediated Dilation in Polycystic Ovary Syndrome (NA)
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:
- Metformin plus Yasmin CI brief — competitive landscape report
- Metformin plus Yasmin updates RSS · CI watch RSS
- Catholic University of the Sacred Heart portfolio CI
Frequently asked questions about Metformin plus Yasmin
What is Metformin plus Yasmin?
How does Metformin plus Yasmin work?
What is Metformin plus Yasmin used for?
Who makes Metformin plus Yasmin?
What drug class is Metformin plus Yasmin in?
What development phase is Metformin plus Yasmin in?
What are the side effects of Metformin plus Yasmin?
What does Metformin plus Yasmin target?
Related
- Drug class: All Combination therapy: biguanide antidiabetic agent + oral contraceptive drugs
- Target: All drugs targeting Metformin: AMP-activated protein kinase (AMPK) pathway; Yasmin: progesterone receptor and estrogen receptor
- Manufacturer: Catholic University of the Sacred Heart — full pipeline
- Therapeutic area: All drugs in Endocrinology / Contraception
- Indication: Drugs for Type 2 diabetes or prediabetes in women requiring contraception
- Indication: Drugs for Polycystic ovary syndrome (PCOS) with metabolic dysfunction
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing