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Pharmacokinetic
Pharmacokinetic is a Biologic drug developed by Centre Oscar Lambret. It is currently in Phase 2 development. Also known as: GTS-21.
Pharmacokinetics is a branch of pharmacology that studies how the body affects a specific substance after administration, including pharmaceutical drugs. A pharmacokinetic study of udenafil was conducted to analyze its fate in adult subjects with or without impaired hepatic function.
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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 | Pharmacokinetic |
|---|---|
| Also known as | GTS-21 |
| Sponsor | Centre Oscar Lambret |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers (PHASE1)
- A Safety Assessment of Oral Letermovir in Infants With Symptomatic Congenital Cytomegalovirus (PHASE1)
- Pharmacokinetic and Subjective Effects of Heated Tobacco Products (NA)
- Comparison of Two Dosage Adjustment Strategies of Vancomycin in Children (NA)
- A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (PHASE1)
- A Pharmacokinetic Study of VCT220 With Moderate Renal Impairment Patients (PHASE1)
- A Study to Find Out How Litifilimab is Processed in the Body in Healthy Participants When Given Under the Skin in 3 Different Ways (PHASE1)
- Pharmacokinetics and Pharmacodynamics of Nicotine With Use of Standardized Research Electronic Cigarette (SREC) (NA)
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:
- Pharmacokinetic CI brief — competitive landscape report
- Pharmacokinetic updates RSS · CI watch RSS
- Centre Oscar Lambret portfolio CI
Frequently asked questions about Pharmacokinetic
What is Pharmacokinetic?
Who makes Pharmacokinetic?
Is Pharmacokinetic also known as anything else?
What development phase is Pharmacokinetic in?
Related
- Manufacturer: Centre Oscar Lambret — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: GTS-21
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing