Asset profile
REGEND001
Cell therapy
Evidence outlook · registrational
Chronic Obstructive Pulmonary Disease: registrational readout pending
Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2028-09.
NCT05638776: The trial randomly assigned 58 participants to REGEND001 or placebo and blinded participants, but the primary outcome was change in DLCO, a physiological surrogate rather than a direct clinical outcome. Because the registry does not report whether this primary comparison was successful, the evidence is currently limited to the trial design.
Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
43 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 43 same-indication; 15 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| REGEND001: this drug | Phase 3 | Cell therapy | Airway epithelial regeneration (autologous basal cells) | ||
| Aclidinium Bromide (Tudorza Pressair) | Approved | Small molecule | Muscarinic acetylcholine receptor (M3) | ||
| Aclidinium Bromide / Formoterol Fumarate (Duaklir Pressair) | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor | ||
| Benralizumab (Fasenra) | Approved | Monoclonal antibody | IL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils | ||
| Budesonide / Glycopyrrolate / Formoterol Fumarate (Breztri Aerosphere) | Approved | Small molecule | Glucocorticoid receptor; Muscarinic M3; Beta-2 adrenergic | ||
| Depemokimab | Approved | Monoclonal antibody | IL-5 | ||
| Ensifentrine (Ohtuvayre) | Approved | Small molecule | PDE3/PDE4 | ||
| Fluticasone Furoate / Umeclidinium / Vilanterol (Trelegy Ellipta) | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination) | ||
| Glycopyrrolate / Formoterol Fumarate (Bevespi Aerosphere) | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor | ||
| Mepolizumab (Nucala) | Approved | Monoclonal antibody | IL-5, Interleukin-5 (IL-5), ligand-neutralizing | ||
| Olodaterol | Approved | Small molecule | Beta-2 adrenergic receptor | ||
| Olodaterol / Tiotropium Bromide | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor | ||
| Revefenacin (Yupelri) | Approved | Small molecule | Muscarinic receptors (antagonist) | ||
| Tiotropium Bromide | Approved | Small molecule | Muscarinic acetylcholine receptor (M3) | ||
| Umeclidinium (Incruse Ellipta) | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), M3 muscarinic acetylcholine receptor | ||
| Umeclidinium / Vilanterol | Approved | Small molecule | Muscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor |
…and 28 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
(4 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2028 (1)
September 2028 (1)
What to watch
2029 (3)
May 2029 (1)
What to watch
June 2029 (1)
What to watch
December 2029 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.