Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GZ389988 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| GZ389988 | EXPERIMENTAL | Single intraarticular injection of GZ389988 in the knee joint |
| Placebo | PLACEBO_COMPARATOR | Single intraarticular injection of placebo for GZ389988 in the knee joint |
| Name | Type | Description |
|---|---|---|
| placebo | DRUG | Pharmaceutical form:solvent for parenteral use Route of administration: intraarticular |
| GZ389988 | DRUG | Pharmaceutical form:suspension for injection Route of administration: intraarticular |
| acetaminophen or paracetamol | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| fixed combination of paracetamol + codeine | DRUG | Pharmaceutical form: capsule Route of administration: oral |
| fixed combination of paracetamol + tramadol hydrochloride | DRUG | Pharmaceutical form: tablet Route of administration: oral |
Inclusion criteria : * Men or women 40 to 80 years of age. * Diagnosis of primary knee osteoarthritis (OA), based upon the following: * Fulfilling the American College of Rheumatology Clinical and Radiographic criteria for OA (at least knee pain and osteophytes), with * X-ray evidence within the la...
GZ389988 is an investigational small molecule being developed for osteoarthritis, specifically for painful osteoarthritis of the knee. It is administered as a single intra-articular injection directly into the knee joint. The drug is currently in clinical development and has not been approved by regulatory authorities.
GZ389988 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's efficacy, tolerability, and safety in patients with painful osteoarthritis of the knee.
GZ389988 is in Phase 2 clinical development. A Phase 1 first-in-human study and a Phase 2 proof-of-concept study have both been completed. The drug remains investigational and has not received regulatory approval for any indication.
GZ389988 has been studied in two completed clinical trials. The first, NCT02424942, was a Phase 1 first-in-human study with ascending single intra-articular doses in 28 patients with painful knee osteoarthritis. The second, NCT02845271, was a Phase 2 proof-of-concept study comparing a single dose against placebo in 104 patients.
GZ389988 is administered as a single intra-articular injection, meaning it is injected directly into the knee joint. This route of administration is used in both the Phase 1 and Phase 2 clinical trials for patients with painful osteoarthritis of the knee.