MOTOFEN (atropine sulfate)
MOTOFEN is indicated for the treatment of Diarrhea.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1978-07-14
- Routes
- ORAL
- Dosage Forms
- TABLET
MOTOFEN Approval History
What MOTOFEN Treats
1 indicationsMOTOFEN is approved for 1 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diarrhea
MOTOFEN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to MOTOFEN
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05470881 PRO-201 results posted | SOPH201-0521/I | Ph 1 | completed | Phase I Clinical Trial to Evaluate the Safety and Tolerability of Ophtalmic Solution PRO-201 |
| NCT06697522 | Protocol V 7.0 | Ph 3 | completed | Study of Atropine Sulfate Eye Drops(0.01%) in Treating Near-work-induced Transient Myopia in Children |
| NCT05481489 PRO-230 | SOPH230-1121/I | Ph 1 | withdrawn | Safety and Tolerability Evaluation of PRO-230 Ophthalmic Solution |
| NCT03690089 CHAMP-UK | 17097AB-AS 2017-004108-23 | Ph 2 | active not recruiting | Low-dose Atropine Eye Drops to Reduce Progression of Myopia in Children in the United Kingdom |
| NCT05372991 | CBT-CS201 | Ph 1, Ph 2 | completed | Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop |
| NCT03932578 | MSA10 | Ph 4 | completed | Intrathecal Atropine vs IV Metoclopramide for Nausea & Vomiting During CS |
| NCT01858090 | KA08/48 | Ph 3 | completed | Intrathecal Levobupivacaine With Opioids for Caesarean Section |
| NCT00947596 | PRO07030057 | Ph 1 | completed | A Study of Inhaled Atropine Sulfate in Healthy Adults |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MOTOFEN FDA Label Details
Indications & Usage
FDA Label (PDF)MOTOFEN is indicated for the treatment of Diarrhea.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment