Asset profile
ORMD-0801
Peptide
Evidence outlook · lead readout
NCT04606576 · Type 2 Diabetes Mellitus
The lead readout missed its primary endpoint. The grade and rationale below record what the trial was designed to show and what it found. A further registrational readout is expected around 2027-04-25.
NCT04606576: This is a large, randomized, fully blinded, placebo-controlled trial using blood sugar control (A1C), the standard disease-defining measure for diabetes, as its primary endpoint, a well-designed setup for showing a real treatment effect. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.
Also in development:Metabolic Dysfunction-Associated Steatohepatitis
How the evidence outlook works ↗
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
89 competitors in this universe: 19 direct rivals (same mechanism and indication), 1 same-class, 69 same-indication; 34 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| ORMD-0801: this drug | Phase 3 | Peptide | Insulin receptor (basal) | ||
| Afrezza | Approved | Peptide | Insulin receptor (basal), Insulin | ||
| Insulin Degludec (Tresiba) | Approved | Peptide | Insulin receptor (basal) | ||
| Insulin Detemir (Levemir) | Approved | Peptide | Insulin receptor (basal) | ||
| Insulin Glargine (Lantus / Toujeo) | Approved | Peptide | Insulin receptor (basal) | ||
| Insulin Glulisine (Apidra) | Approved | Peptide | Insulin receptor (basal) | ||
| Insulin Icodec (Awiqli) | Approved | Peptide | Insulin receptor (basal) | ||
| Insulin Lispro (Humalog) | Approved | Peptide | Insulin receptor (basal) | ||
| LY2963016 (Basaglar) | Approved | Peptide | Insulin receptor (basal) | ||
| LY900014 (Lyumjev) | Approved | Peptide | Insulin receptor (basal) | ||
| SAR341402 | Approved | Peptide | Insulin receptor (basal) | ||
| GZR33 | Phase 3 | Peptide | Insulin receptor (basal) | ||
| IcoSema (Kyinsu) | Phase 3 | Peptide | Insulin receptor (basal), GLP-1 receptor | ||
| INS068 | Phase 3 | Peptide | Insulin receptor (basal) | ||
| Insulin Efsitora Alfa | Phase 3 | Protein / enzyme therapeutic | Insulin receptor (basal) | ||
| THDB0206 | Phase 3 | Peptide | Insulin receptor (basal) |
…and 74 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.
Compare head-to-head
13 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.
Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (1)
April 2027 (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.