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Single drug references
Single drug references is a Small molecule drug developed by Pfizer. It is currently in Phase 1 development.
CKD-387 is a drug being studied in a clinical trial (NCT05673369) for its pharmacokinetic profiles and safety under fasting conditions. The exact mechanism of CKD-387 is currently unknown, as indicated by ChEMBL.
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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). -
Big-pharma sponsor
+3.0pp
Pfizer 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 | 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 | Single drug references |
|---|---|
| Sponsor | Pfizer |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest Solution for IM Injection With the Reference Product, Progesterone Injection (PHASE1)
- The Impact of Music Medicine on Preterm Brain Development and Behavior (NA)
- Human Bioequivalence Study of Liposomal Amphotericin B for Injection (NA)
- A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fed Conditions (PHASE1)
- A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 in Healthy Adult Subjects (PHASE1)
- Bioequivalence Study of Nalfurafine Hydrochloride Orally Disintegrating Tablets on Fasting and Fed in Humans (NA)
- Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis Treatment (PHASE4)
- A Bioequivalence Study of Advil Tablet (Mini) (Ibuprofen 200 mg) Versus Advil Tablet (Ibuprofen 200 mg) in Healthy Adult Subjects Under Fasted Conditions and Bioavailability Assessment of Advil Tablet (Mini) Under Fed Conditions (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:
- Single drug references CI brief — competitive landscape report
- Single drug references updates RSS · CI watch RSS
- Pfizer portfolio CI
Frequently asked questions about Single drug references
What is Single drug references?
Who makes Single drug references?
What development phase is Single drug references in?
Related
- Manufacturer: Pfizer — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing