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One dose Diclofenac
One dose Diclofenac is a Small molecule drug developed by Universidad Autonoma de Baja California. It is currently in Phase 1 development. Also known as: Diclofenaco.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | One dose Diclofenac |
|---|---|
| Also known as | Diclofenaco |
| Sponsor | Universidad Autonoma de Baja California |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Counterpain PXM Versus Diclofenac Versus Piroxicam (PHASE3)
- Helping Osteoarthritis Patients to Walk With NSAID (PHASE4)
- Effect of Single Dose Intravenous Magnesium Sulfate on Postoperative Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy (PHASE4)
- Gabapentin and Diclofenac Sodium Comparison for Post-Operative Pain Relief (NA)
- The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain (NA)
- Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws (NA)
- Exercise vs. Topical Diclofenac vs. PRP (NA)
- Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (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:
- One dose Diclofenac CI brief — competitive landscape report
- One dose Diclofenac updates RSS · CI watch RSS
- Universidad Autonoma de Baja California portfolio CI
Frequently asked questions about One dose Diclofenac
What is One dose Diclofenac?
Who makes One dose Diclofenac?
Is One dose Diclofenac also known as anything else?
What development phase is One dose Diclofenac in?
Related
- Manufacturer: Universidad Autonoma de Baja California — full pipeline
- Also known as: Diclofenaco
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing