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TAK-625
TAK-625 is a GLP-1 receptor agonist Small molecule drug developed by Takeda. It is currently in Phase 3 development for Type 2 diabetes. Also known as: Maralixibat chloride.
TAK-625 is a glucagon-like peptide-1 (GLP-1) receptor agonist.
TAK-625 is a glucagon-like peptide-1 (GLP-1) receptor agonist. Used for Type 2 diabetes.
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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
Takeda 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 | TAK-625 |
|---|---|
| Also known as | Maralixibat chloride |
| Sponsor | Takeda |
| Drug class | GLP-1 receptor agonist |
| Target | GLP-1R |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
TAK-625 works by mimicking the action of the natural hormone GLP-1, which helps to lower blood sugar levels by enhancing glucose-dependent insulin secretion, suppressing inappropriately elevated glucagon secretion, and slowing gastric emptying.
Approved indications
- Type 2 diabetes
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
Key clinical trials
- A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
- A Study of TAK-625 for the Treatment of Alagille Syndrome (ALGS) (PHASE3)
- A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) (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:
- TAK-625 CI brief — competitive landscape report
- TAK-625 updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about TAK-625
What is TAK-625?
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What is TAK-625 used for?
Who makes TAK-625?
Is TAK-625 also known as anything else?
What drug class is TAK-625 in?
What development phase is TAK-625 in?
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What does TAK-625 target?
Related
- Drug class: All GLP-1 receptor agonist drugs
- Target: All drugs targeting GLP-1R
- Manufacturer: Takeda — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Type 2 diabetes
- Also known as: Maralixibat chloride