Asset profile

ensifentrine · Ohtuvayre

Small molecule

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Approvedregulatory verdict

Evidence outlook

Approved: Chronic Obstructive Pulmonary Disease

Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.

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.

track record: Reliable signal

How the evidence outlook works ↗

Competitive landscape

43 competitors in this universe: 2 direct rivals (same mechanism and indication), 0 same-class, 41 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Ensifentrine (Ohtuvayre): this drugApprovedSmall moleculePDE3/PDE4
TQC3721Phase 3Small moleculePDE3/PDE4
HRS-9821Phase 2Small moleculePDE3/PDE4
Aclidinium Bromide (Tudorza Pressair)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3)
Aclidinium Bromide / Formoterol Fumarate (Duaklir Pressair)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-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)ApprovedSmall moleculeGlucocorticoid receptor; Muscarinic M3; Beta-2 adrenergic
DepemokimabApprovedMonoclonal antibodyIL-5
Fluticasone Furoate / Umeclidinium / Vilanterol (Trelegy Ellipta)ApprovedSmall moleculeMuscarinic 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)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Mepolizumab (Nucala)ApprovedMonoclonal antibodyIL-5, Interleukin-5 (IL-5), ligand-neutralizing
OlodaterolApprovedSmall moleculeBeta-2 adrenergic receptor
Olodaterol / Tiotropium BromideApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), Beta-2 adrenergic receptor
Revefenacin (Yupelri)ApprovedSmall moleculeMuscarinic receptors (antagonist)
Tiotropium BromideApprovedSmall moleculeMuscarinic acetylcholine receptor (M3)
Umeclidinium (Incruse Ellipta)ApprovedSmall moleculeMuscarinic acetylcholine receptor (M3), M3 muscarinic acetylcholine receptor

…and 28 more. Research shows the complete landscape.

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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

(2 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (2)
March 2027 (1)
Phase 2Chronic Obstructive Pulmonary DiseaseActive not recruiting
Est. primary completion 2027-03-01 · NCT05270525 · CT.gov ↗
What to watch
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September 2027 (1)
Phase 2Non-cystic Fibrosis BronchiectasisRecruiting
Est. primary completion 2027-09-24 · NCT06559150 · CT.gov ↗
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See the full readout calendar ↗

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.

Phase 3 (4)
Phase 2 (13)
Phase 1 (2)
Appears in other studies (1)