Arthrosamid in the US: FDA Timeline
Current FDA status of Arthrosamid for US patients in 2026, clinical trial pathway, estimated approval timeline, and what alternatives are available now.
By Joint Pain Authority Team
Quick Answer
Arthrosamid is not yet available in the United States as of March 2026. It is approved in the EU, UK, Australia, and Canada, but FDA approval requires completing US-specific clinical trials. The manufacturer (Contura) is conducting a pivotal Phase 3 trial in the US, with results expected in late 2026 or 2027. If successful, the earliest possible FDA approval would be 2027-2028. US patients cannot legally receive Arthrosamid domestically. In the meantime, gel injections (HA viscosupplementation) remain the most comparable FDA-approved alternative.
What Is Arthrosamid?
Arthrosamid is a non-biodegradable polyacrylamide hydrogel (iPAAG) injected directly into the knee joint. Unlike hyaluronic acid gel shots that are gradually absorbed by the body, Arthrosamid is designed to integrate permanently into the synovial membrane (the joint lining) and provide long-term cushioning and lubrication.
Key Characteristics
| Feature | Detail |
|---|---|
| Composition | 2.5% polyacrylamide, 97.5% water |
| Mechanism | Integrates into synovial membrane; restores cushioning |
| Injection count | Single injection |
| Designed duration | Long-term (potentially years from one injection) |
| Manufacturer | Contura International (Denmark) |
| Classification | Medical device (not a drug) |
For a comprehensive overview of the treatment itself, read our Arthrosamid knee injection guide.
Current FDA Status (March 2026)
Arthrosamid has NOT been approved by the FDA.
It is currently classified as an investigational product in the United States. This means:
- It cannot be legally marketed or sold in the US
- It cannot be administered by US physicians outside of clinical trials
- Patients cannot import it for personal use
- Any US clinic offering Arthrosamid outside of an approved trial is operating improperly
Where Arthrosamid IS Approved
| Country/Region | Status | Approved Since |
|---|---|---|
| European Union | CE marked | 2021 |
| United Kingdom | Approved | 2022 |
| Australia | TGA approved | 2023 |
| Canada | Health Canada approved | 2025 |
| United States | Not approved; Phase 3 trial | — |
The Canada approval in 2025 was a significant milestone because Health Canada has rigorous standards similar to the FDA. This approval is viewed as a positive signal for the eventual US pathway, though it does not guarantee FDA approval.
The FDA Approval Pathway
Clinical Trial Progress
Safety and preliminary efficacy established in EU trials. Data showed significant pain reduction with an acceptable safety profile over 2+ years of follow-up.
A large, randomized, double-blind, saline-controlled trial is underway at multiple US centers. This is the critical study the FDA requires before considering approval. Enrollment is ongoing.
Contura will submit a Premarket Approval (PMA) application after Phase 3 results are available. The FDA then has up to 180 days for standard review, though the process often takes longer.
Estimated Timeline
| Milestone | Estimated Date |
|---|---|
| Phase 3 trial enrollment complete | Mid 2026 |
| Phase 3 primary endpoint data | Late 2026 - Early 2027 |
| PMA submission to FDA | 2027 |
| FDA review period | 6-12 months |
| Possible FDA decision | Late 2027 - Mid 2028 |
| Commercial availability (if approved) | 2028 at earliest |
These are optimistic estimates assuming the trial succeeds and the FDA review proceeds smoothly. Delays are common. The FDA may request additional data or longer follow-up. Trial results may not match international data. Approval is not guaranteed. Patients should plan their current treatment around what is available today, not what may be available in 2-3 years.
What International Data Shows
While we cannot use international approval as a substitute for FDA review, the global data is worth understanding.
Published Clinical Results
However, the FDA will make its own independent assessment based on the US trial data. International approvals inform but do not determine the US regulatory outcome.
For detailed comparisons with existing treatments, see:
What US Patients Can Do Now
If you are interested in Arthrosamid, here are your current options and the best alternatives available today.
Option 1: Participate in a Clinical Trial
If you meet eligibility criteria, you may be able to receive Arthrosamid through the active US clinical trial. Search ClinicalTrials.gov for “Arthrosamid knee osteoarthritis” to find enrolling sites. Trial participation is typically free and includes medical monitoring.
Typical eligibility requirements:
- Confirmed knee OA (usually KL Grade 2-3)
- Age 40+
- Failed conservative treatment
- No prior joint replacement on the study knee
- Willingness to follow the study protocol and attend follow-up visits
Option 2: Use Proven Alternatives Now
The smartest approach for most patients is to use treatments that are available, proven, and covered by insurance today.
What About Medical Tourism?
Some patients ask about traveling to Canada, the UK, or EU to receive Arthrosamid. While the treatment is available in those countries, this approach has significant drawbacks:
We are not advising against this option, but patients should weigh these factors carefully and consider whether FDA-approved alternatives might serve them well in the interim.
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When will Arthrosamid be available in the US?
The earliest realistic estimate is 2028, assuming the Phase 3 trial produces positive results, the FDA review proceeds without delays, and approval is granted. This timeline could extend to 2029 or later if additional data is requested. There is also a possibility that the trial does not meet its endpoints, which would further delay or prevent US availability.
Can my doctor get Arthrosamid for me through a special program?
No. There is no compassionate use or expanded access program for Arthrosamid in the US at this time. The only way to receive it within the US is through participation in the active clinical trial. Your doctor cannot order it, import it, or administer it outside of the trial framework.
How is Arthrosamid different from gel shots?
The key difference is permanence. Gel shots (hyaluronic acid) are biodegradable and are absorbed by the body over months, requiring repeat treatments. Arthrosamid is non-biodegradable and integrates permanently into the joint lining, potentially providing years of benefit from a single injection. However, this permanence also means that if there are issues, the material cannot be removed. See our detailed comparison.
Will Medicare cover Arthrosamid when it is approved?
This is unknown. Medicare coverage decisions are made separately from FDA approval and can take additional time. Given that Medicare already covers gel injections for knee OA, there is a reasonable basis for eventual coverage, but it is not guaranteed. The cost of Arthrosamid compared to existing treatments will likely factor into coverage decisions.
Should I wait for Arthrosamid instead of getting gel shots now?
For most patients, waiting is not advisable. Arthrosamid is at least 2 years from availability, and there is no guarantee of approval. Meanwhile, your knee arthritis continues to progress. Gel injections are available now, covered by insurance, and have strong evidence. They can also delay the need for surgery while you wait for new options to become available. Treating now does not prevent you from switching to Arthrosamid later if it is approved.
References
-
Contura International. Arthrosamid clinical development program overview.
-
ClinicalTrials.gov. Phase 3 study of Arthrosamid for knee osteoarthritis in the United States.
-
Henriksen M, et al. Arthrosamid for knee osteoarthritis: 2-year follow-up results. Osteoarthritis and Cartilage, 2024.
-
Health Canada. Arthrosamid medical device license, 2025.
-
European Medicines Agency (CE marking). Arthrosamid approval documentation.
Related Articles
Arthrosamid Information
- Arthrosamid: New Knee Injection in 2026
- Arthrosamid Knee Injection Guide
- Medicare and Arthrosamid Coverage
Comparisons
- Arthrosamid vs. Gel Injections
- Arthrosamid vs. Synvisc
- Arthrosamid vs. Hyaluronic Acid
- Arthrosamid vs. Durolane
Available Treatments Now
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