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ORMD-0801 Dose # 1
ORMD-0801 Dose # 1 is a Small molecule drug developed by Oramed, Ltd.. It is currently in Phase 2 development. Also known as: Oral Insulin.
ORMD-0801 was studied in a Phase 2b clinical trial (NCT03467932) for its efficacy and safety in patients with Type 2 Diabetes Mellitus, as well as other conditions including Type 1 Diabetes and Nonalcoholic Steatohepatitis. The trial involved two cohorts, one receiving ORMD-0801 and the other a placebo, both administered orally.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | ORMD-0801 Dose # 1 |
|---|---|
| Also known as | Oral Insulin |
| Sponsor | Oramed, Ltd. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH) (PHASE2)
- A Study to Evaluate the Efficacy and Safety of ORMD-0801 (Oral Insulin) in Patients With Type 2 Diabetes Mellitus (PHASE2)
- Phase II Safety and Efficacy Study of Oral ORMD-0801 in Patients With Type 2 Diabetes Mellitus (PHASE2)
- A Euglycemic Insulin Clamp Study in Type 1 Diabetic Patients With Oral Insulin (ORAMED) (PHASE2)
- A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus (PHASE2)
- Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Multiple Oral Bedtime Doses of ORMD-0801 in Adult Patients With Type 2 Diabetes Mellitus (T2DM) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ORMD-0801 Dose # 1 CI brief — competitive landscape report
- ORMD-0801 Dose # 1 updates RSS · CI watch RSS
- Oramed, Ltd. portfolio CI
Frequently asked questions about ORMD-0801 Dose # 1
What is ORMD-0801 Dose # 1?
Who makes ORMD-0801 Dose # 1?
Is ORMD-0801 Dose # 1 also known as anything else?
What development phase is ORMD-0801 Dose # 1 in?
Related
- Manufacturer: Oramed, Ltd. — full pipeline
- Also known as: Oral Insulin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing