Head-to-head evidence
CL-197 vs Doravirine
Same mechanism, same race: design-graded trial evidence for both assets, with the grading rationale shown. Grades describe the quality of the evidence, never the merits of either security.
HIV
Shared mechanism: HIV reverse transcriptase · full HIV pipeline
CL-197
Developed by Henan Genuine Biotech
NCT05944848 · Phase 1 · completed
The study randomly assigned healthy volunteers to active drug or matching placebo and blinded participants, care providers, investigators, and outcome assessors, which are the hallmarks of a well-controlled study. However, it tested only safety and drug levels in healthy volunteers rather than any HIV outcome, and results have not been posted.
Next expected readout: December 2026 · NCT07308782 (registry estimate)
Doravirine · Pifeltro
Marketed by Merck & Co.
NCT02275780 · Phase 3 · completed
This was a randomized, double-blind, active-controlled Phase 3 trial with 769 enrolled adults (385 doravirine, 384 darunavir/ritonavir). The primary endpoint was virologic suppression (HIV-1 RNA <50 copies/mL) at Week 48, a hard clinical endpoint. The non-inferiority comparison was met: the difference was 3.9 percentage points (95% CI -1.6 to 9.4), with the lower bound above the prespecified -10% margin. The trial therefore provides strong evidence that doravirine is non-inferior to darunavir/ritonavir.
Next expected readout: November 2026 · NCT04892654 (registry estimate)
The full competitive landscape for each asset (every same-race competitor with aligned evidence, sortable) is on the asset pages: CL-197's landscape · Doravirine's landscape