PONSTEL (mefenamic acid) · AVION PHARMS
Ponstel is a nonsteroidal anti-inflammatory drug used to manage mild to moderate pain in adults and adolescents at least 14 years of age. It also helps patients with primary dysmenorrhea, providing relief from menstrual-related discomfort. To minimize potential risks, this medication is typically prescribed for short-term use, generally not exceeding one week.
How PONSTEL Works
This medication works by inhibiting the COX-1 and COX-2 enzymes, which leads to a decrease in the production of prostaglandins in peripheral tissues. Since prostaglandins are responsible for sensitizing nerves and mediating inflammation, reducing their levels helps relieve pain and reduce fever.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1967-03-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
PONSTEL Approval History
What PONSTEL Treats
2 indicationsPONSTEL is approved for 2 conditions since its original approval in 1967. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Pain
- Dysmenorrhea
PONSTEL Boxed Warning
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (see Warnings ). Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see Contraindications , Warnings ). G...
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. (see Warnings ). Mefenamic acid is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see Contraindications , Warnings ). Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see Warnings ).
PONSTEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 PONSTEL
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07466342 | U1111-1336-6691 | Ph 4 | completed | Vitamin E Plus Mefenamic Acid Versus Mefenamic Acid Alone for Treating Primary Dysmenorrhea in Women |
| NCT06277609 | 20508A | Ph 1 | completed | A Trial Investigating Lu AF28996 in Healthy Adult Participants |
| NCT05064449 results posted | TAK-935-1007 | Ph 1 | completed | A Study of Soticlestat With Itraconazole and Mefenamic Acid in Healthy Adults |
| NCT03070678 | INT14937 U1111-1186-2702 | Ph 1 | completed | Interaction Study to Evaluate the Effects of Mefenamic Acid on the Pharmacokinetics and Pharmacodynamics of Sotagliflozin in Healthy Male and Female Subjects |
| NCT01942122 | DLBS1442-0212 | Ph 2, Ph 3 | completed | DLBS1442 for The Treatment of Pain in Patients Suspected Endometriosis |
| NCT04902105 | EBS-101-HV-102 | Ph 1 | completed | Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite |
| NCT03323671 | 27011975 | Ph 2, Ph 3 | completed | Preemptive Analgesia for Primary Dysmenorrhoea |
| NCT02417337 NSAID results posted | University of Khartoum | Ph 2 | completed | Efficacy of Different Drugs to Control Post Root Canal Treatment Pain |
| NCT01295294 | 15105 2010-020922-16 | Ph 4 | completed | Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA) |
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.
PONSTEL FDA Label Details
Indications & Usage
FDA Label (PDF)Carefully consider the potential benefits and risks of mefenamic acid capsules and other treatment options before deciding to use mefenamic acid capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ; Gastrointestinal Bleeding, Ulceration, and Perforation ). Mefenamic acid capsules are indicated: For relief of mild to moderate pain in patients ≥14 years of age, when therapy will not exceed one week (7 days). For treatment of primary dysmenorrhea.
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur ...
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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