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DIDALA hard capsules
DIDALA hard capsules is a SSRI Small molecule drug developed by Centre of Clinical Pharmacology, Hanoi Medical University. It is currently in Phase 3 development for Major depressive disorder, Anxiety disorders.
DIDALA hard capsules are a selective serotonin reuptake inhibitor (SSRI) that works by increasing the levels of serotonin in the brain.
DIDALA hard capsules are a selective serotonin reuptake inhibitor (SSRI) that works by increasing the levels of serotonin in the brain. Used for Major depressive disorder, Anxiety disorders.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| 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 | DIDALA hard capsules |
|---|---|
| Sponsor | Centre of Clinical Pharmacology, Hanoi Medical University |
| Drug class | SSRI |
| Target | Serotonin transporter |
| Modality | Small molecule |
| Therapeutic area | Psychiatry |
| Phase | Phase 3 |
Mechanism of action
This increase in serotonin levels helps to improve mood, reduce anxiety, and prevent the recurrence of depression. SSRIs like DIDALA are commonly used to treat major depressive disorder, anxiety disorders, and other conditions.
Approved indications
- Major depressive disorder
- Anxiety disorders
Common side effects
- Nausea
- Headache
- Dizziness
- Insomnia
- Fatigue
Key clinical trials
- Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin. (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:
- DIDALA hard capsules CI brief — competitive landscape report
- DIDALA hard capsules updates RSS · CI watch RSS
- Centre of Clinical Pharmacology, Hanoi Medical University portfolio CI
Frequently asked questions about DIDALA hard capsules
What is DIDALA hard capsules?
How does DIDALA hard capsules work?
What is DIDALA hard capsules used for?
Who makes DIDALA hard capsules?
What drug class is DIDALA hard capsules in?
What development phase is DIDALA hard capsules in?
What are the side effects of DIDALA hard capsules?
What does DIDALA hard capsules target?
Related
- Drug class: All SSRI drugs
- Target: All drugs targeting Serotonin transporter
- Manufacturer: Centre of Clinical Pharmacology, Hanoi Medical University — full pipeline
- Therapeutic area: All drugs in Psychiatry
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Anxiety disorders
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing