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Diclectin
Diclectin is a Small molecule drug developed by Xiaoke Wu. It is currently in Phase 3 development. Also known as: Doxylamine + Pyridoxine, Delayed-release Tablets.
Diclectin is a combination of pyridoxine hydrochloride (vitamin B6) and doxylamine succinate, a small molecule. It is used to treat nausea and vomiting of pregnancy, as well as related conditions such as hyperemesis gravidarum and morning sickness.
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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 | Diclectin |
|---|---|
| Also known as | Doxylamine + Pyridoxine, Delayed-release Tablets |
| Sponsor | Xiaoke Wu |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Pharmacokinetics and Bioequivalence of Doxylamine+Pyridoxine and Diclectin Under Fed Conditions in Healthy Volunteers (PHASE1)
- Pharmacokinetics and Bioequivalence of Doxylamine + Pyridoxine, Film-coated, Enteric-soluble Tablets, and Diclectin, Delayed Release Tablets, in Healthy Volunteers (NA)
- Effectiveness of Acupuncture and Doxylamine/Pyridoxine for Moderate to Severe Nausea and Vomiting in Pregnancy (PHASE3)
- The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy (PHASE3)
- Pre-emptive Treatment of Severe Nausea and Vomiting of Pregnancy (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:
- Diclectin CI brief — competitive landscape report
- Diclectin updates RSS · CI watch RSS
- Xiaoke Wu portfolio CI
Frequently asked questions about Diclectin
What is Diclectin?
Who makes Diclectin?
Is Diclectin also known as anything else?
What development phase is Diclectin in?
Related
- Manufacturer: Xiaoke Wu — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Doxylamine + Pyridoxine, Delayed-release Tablets
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing