Table 2.
Most developed drug candidates for idiopathic pulmonary fibrosis.
| Compound | Mechanism of action | Study design | Primary outcome/study duration | Developmental phase/status | Clinical trial identifier |
|---|---|---|---|---|---|
| Inhaled TD139 | Galectin-3 inhibitor | Phase 1: randomized, placebo-controlled, single ascending dose. Phase 2: randomized, placebo-controlled, multiple dose expansion cohort | Safety and tolerability (number of participant with adverse events over 2 weeks) | Phase I/II; completed, awaiting results | NCT02257177 |
| PRM-151 | Recombinant human Pentraxin-2 (serum amyloid P). Antifibrotic immunomodulator. | Randomized, placebo-controlled | Change in FVC % predicted from baseline through week 28 | Phase II; active, not recruiting | NCT02550873 |
| KD025 | ROCK2 inhibitor | Randomized, open-label, active comparator | Change in FVC from baseline through week 24 | Phase II; recruiting | NCT02688647 |
| Tipelukast | LT receptor antagonist, PDE 3 and 4 inhibitor, 5-LO inhibitor | Randomized, placebo-controlled | Change in FVC from baseline through week 26 | Phase II; recruiting | NCT02503657 |
| PBI-4050 | CTGF, α-SMA and collagen I expression inhibitor | Open-label, single-arm | Safety and tolerability (number of participant with abnormal laboratory values and/or adverse events over 9 months) | Phase II; completed, awaiting results | NCT02538536 |
| GLPG1690 | Autotaxin inhibitor | Randomized, placebo-controlled | Safety and tolerability over 12 weeks; pharmacokinetics; concentration of lysophosphatidic acid in blood/bronchoalveolar lavage | Phase II; Completed, awaiting results | NCT02738801 |
| CC-90001 | JNK inhibitor | Randomized, placebo-controlled | Change in FVC % predicted from baseline through week 24 | Phase II; recruiting | NCT03142191 |
| BMS-986020 | LPA receptor inhibitor | Randomized, placebo-controlled | Rate of change in FVC at week 26 | Phase II; completed, awaiting results | NCT01766817 |
| BG00011 (formerly STX-100) | αvβ6 inhibitor | Randomized, placebo-controlled, dose escalation | Safety and tolerability (number of participant experiencing adverse events over 16 weeks) | Phase II; completed, awaiting results | NCT01371305 |
| Pamrevlumab/FG-3019 | CTGF inhibitor | Randomized, placebo-controlled | Change in FVC from baseline through week 48 | Phase II; active, not recruiting | NCT01890265 |
| Rituximab | CD20 inhibitor | Randomized, placebo-controlled | Change in titers of Autoantibodies to HEp-2 Cells over 9 months | Phase II; completed, awaiting results | NCT01969409 |
| Lebrikizumab | IL-13 inhibitor | Randomized, placebo-controlled and active drug (i.e., pirfenidone) controlled | Rate of decline in FVC % predicted from baseline through week 52 | Phase II; completed, awaiting results | NCT01872689 |
| SAR156597 | IL-4 and IL-13 inhibitor | Randomized, placebo-controlled | Absolute change in FVC from baseline through week 52 | Phase II; completed, awaiting results | NCT02345070 |
CTGF, connective tissue growth factor; FVC, forced vital capacity; HEp-2, Human epithelial type 2; IL, interleukin; JNK, c-Jun N-Terminal Kinase; 5-LO, 5-lipoxygenase; LPA, lysophosphatidic acid; LT, leukotriene; PDE, phosphodiesterase; ROCK2, Rho associated kinase 2; α-SMA, α-smooth muscle actin; TGF-β, transforming growth factor-β.