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PDC-1421 Capsule
PDC-1421 Capsule is a Small molecule drug developed by BioLite, Inc.. It is currently in Phase 2 development. Also known as: Extract of Radix Polygalae, BLI-1005.
PDC-1421 Capsule is a small molecule intervention being studied for its potential efficacy in treating Attention-Deficit Hyperactivity Disorder (ADHD) and Major Depressive Disorder. The capsule is being investigated in a Phase II clinical trial to assess its tolerability and efficacy in adult patients with ADHD.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | PDC-1421 Capsule |
|---|---|
| Also known as | Extract of Radix Polygalae, BLI-1005 |
| Sponsor | BioLite, Inc. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients (PHASE1, PHASE2)
- PDC-1421 Treatment in Adult Patients With ADHD (PHASE2)
- A Study of PDC-1421 Treatment in Adult Patients With Attention-Deficit Hyperactivity Disorder (ADHD) (PHASE2)
- A Phase II Study of PDC-1421 Capsule to Evaluate the Safety and Efficacy in Patients With Major Depressive Disorder (PHASE2)
- A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression (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:
- PDC-1421 Capsule CI brief — competitive landscape report
- PDC-1421 Capsule updates RSS · CI watch RSS
- BioLite, Inc. portfolio CI
Frequently asked questions about PDC-1421 Capsule
What is PDC-1421 Capsule?
Who makes PDC-1421 Capsule?
Is PDC-1421 Capsule also known as anything else?
What development phase is PDC-1421 Capsule in?
Related
- Manufacturer: BioLite, Inc. — full pipeline
- Also known as: Extract of Radix Polygalae, BLI-1005
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing