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Formulation E
Formulation E is a gastric-resident capsule that delivers oral medications in an extended-release manner by adhering to the stomach lining.
Formulation E is a gastric-resident capsule that delivers oral medications in an extended-release manner by adhering to the stomach lining. Used for Extended-release oral drug delivery platform (non-indication-specific technology).
At a glance
| Generic name | Formulation E |
|---|---|
| Also known as | Placebo capsule, nosocomial pneumonia, MIC, JNJ-53718678 |
| Sponsor | Lyndra Inc. |
| Modality | Small molecule |
| Therapeutic area | Drug Delivery / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Lyndra's Formulation E uses a proprietary geometry-based approach to create a capsule that unfolds and lodges in the stomach, allowing prolonged drug release over days or weeks. This enables less frequent dosing of medications that would normally require daily administration, improving patient adherence and reducing pill burden.
Approved indications
- Extended-release oral drug delivery platform (non-indication-specific technology)
Common side effects
- Gastrointestinal discomfort
- Nausea
- Abdominal pain
Key clinical trials
- A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Antacid in Healthy Adults (PHASE1)
- Moving on After Breast Cancer Trial for Depressed Breast Cancer Survivors in Pakistan (NA)
- Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer (PHASE2)
- A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation (PHASE2)
- A Study to Investigate the Pharmacokinetics of Different Formulations and Safety of AZD5004 in Healthy Participants Aged 18 to 55 Years (PHASE1)
- Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (PHASE2)
- A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants (PHASE1)
- An Open Label Pharmacokinetic Study of ASP-001 Formulations in Healthy Volunteers (PHASE1)
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:
- Formulation E CI brief — competitive landscape report
- Formulation E updates RSS · CI watch RSS
- Lyndra Inc. portfolio CI