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TAK-438
TAK-438 is a SGLT2 inhibitor Small molecule drug developed by Takeda. It is currently in Phase 3 development for Treatment of type 2 diabetes. Also known as: Vonoprazan.
TAK-438 is a selective and potent inhibitor of the sodium-glucose cotransporter 2 (SGLT2).
TAK-438 is a selective and potent inhibitor of the sodium-glucose cotransporter 2 (SGLT2). Used for Treatment of 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-438 |
|---|---|
| Also known as | Vonoprazan |
| Sponsor | Takeda |
| Drug class | SGLT2 inhibitor |
| Target | SGLT2 |
| Modality | Small molecule |
| Therapeutic area | Diabetes |
| Phase | Phase 3 |
Mechanism of action
By inhibiting SGLT2, TAK-438 reduces glucose reabsorption in the kidneys, leading to decreased glucose levels in the blood. This mechanism is thought to contribute to its therapeutic effects in treating type 2 diabetes.
Approved indications
- Treatment of type 2 diabetes
Common side effects
- Increased risk of genital amputation
- Increased risk of diabetic ketoacidosis
- Increased risk of urinary tract infections
Key clinical trials
- Evaluating the Efficacy of Vonoprazan in Preventing Post-Endoscopic Variceal Band Ligation Ulcers: A Randomized Controlled Trial (PHASE2)
- Special Drug Use Surveillance of Vonoprazan for "Maintenance Therapy of Reflux Esophagitis: Long-term Use"
- A Study to Evaluate the Efficacy and Safety of Bismuth-Containing Quadruple Therapy With Oral Vonoprazan (TAK-438) 20 mg Compared to Esomeprazole 20 mg Twice Daily in Paticipants With Helicobacter Pylori Infection (PHASE3)
- A Study of Vonoprazan in Adults With Helicobacter Pylori (PHASE1)
- Special Drug Use Surveillance of Vonoprazan for "Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs: Long-term Use"
- Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helicobacter Pylori Infection (PHASE3)
- Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helicobacter Pylori Infection (PHASE3)
- A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet (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:
- TAK-438 CI brief — competitive landscape report
- TAK-438 updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about TAK-438
What is TAK-438?
How does TAK-438 work?
What is TAK-438 used for?
Who makes TAK-438?
Is TAK-438 also known as anything else?
What drug class is TAK-438 in?
What development phase is TAK-438 in?
What are the side effects of TAK-438?
What does TAK-438 target?
Related
- Drug class: All SGLT2 inhibitor drugs
- Target: All drugs targeting SGLT2
- Manufacturer: Takeda — full pipeline
- Therapeutic area: All drugs in Diabetes
- Indication: Drugs for Treatment of type 2 diabetes
- Also known as: Vonoprazan
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing