Has the FDA approved any new drugs for peripheral neuropathy in 2024 or 2025?
This fact-check may be outdated. Consider refreshing it to get the most current information.
Executive summary
No single, broad new drug for general peripheral neuropathy was approved by the FDA in 2024 or 2025 according to the supplied reporting; however, the agency cleared several targeted products relevant to nerve pain and specific neuropathies: eplontersen for ATTR‑PN became available Jan 2024 as an approved therapy for hereditary transthyretin amyloidosis with polyneuropathy (reported Dec 2023) [1], Neuralace’s Axon Therapy (a noninvasive magnetic peripheral nerve stimulation device) received FDA clearance for painful diabetic neuropathy in January 2024 [2] [3], and the FDA approved suzetrigine (Journavx) for acute moderate-to-severe pain on Jan 30, 2025 — a drug Vertex is also studying for peripheral neuropathic pain [4] [5].
1. What “approved for peripheral neuropathy” actually means
FDA approvals span drugs for underlying diseases that cause neuropathy, drugs approved to treat neuropathic pain symptoms, and device clearances for neuromodulation; they are not interchangeable. For example, eplontersen was approved to treat transthyretin amyloidosis with polyneuropathy (a specific, rare cause of peripheral neuropathy) and therefore addresses the disease process in that population, not broad diabetic or idiopathic neuropathies [1]. Device clearances such as Neuralace’s Axon Therapy are approvals of a treatment modality for painful diabetic neuropathy (PDN), not a new systemic drug [2] [3].
2. The 2024 approvals and clearances that matter
Reporting shows two relevant actions in 2024: the eplontersen approval was reported in December 2023 and made the drug available in January 2024 as the fourth drug for ATTR‑PN (amyloid polyneuropathy) [1]. Separately, Neuralace Medical announced FDA clearance of its Axon Therapy mPNS system for chronic painful diabetic neuropathy on Jan. 11, 2024; coverage calls this the first FDA clearance of noninvasive magnetic peripheral nerve stimulation for PDN [2] [3].
3. 2025 developments to watch and what was approved
In January 2025 the FDA approved Journavx (suzetrigine) for moderate-to-severe acute pain; Vertex is testing the same agent in peripheral neuropathic pain and painful diabetic peripheral neuropathy, but the FDA approval that month was for acute pain, not a neuropathy indication [4] [5]. Sources note Vertex’s ongoing trials and that the agency accepted suzetrigine’s application for priority review in late January 2025 (community reporting) but do not state an FDA neuropathy indication in the materials provided [6] [5].
4. Where the evidence shows progress — and where it doesn’t
There is clear, cited progress for certain narrow indications: disease‑modifying antisense oligonucleotides like eplontersen for ATTR‑PN (available Jan 2024) [1] and device-based neuromodulation clearance for PDN (Axon Therapy) [2] [3]. Broader approvals for diabetic peripheral neuropathy symptoms continue to rely on older systemic agents (duloxetine, pregabalin, tapentadol, topical capsaicin) and device approvals such as spinal cord stimulation noted in reviews [7] [8] [9]. Sources do not report a new, FDA‑approved systemic drug specifically labeled for general peripheral neuropathy in 2024–2025 outside those niche approvals and device clearances (available sources do not mention a broader approval).
5. Competing perspectives and implicit agendas in reporting
Company press releases and trade outlets emphasize first‑in‑class or “landmark” status (Neuralace PR, PharmExec) and may frame device clearance as a breakthrough for millions [2] [10]. Academic and review literature frames advances more cautiously, placing new approvals in context with longstanding treatments and emphasizing unmet needs and ongoing trials [11] [7]. Market‑analysis pieces highlight commercial impact (e.g., VYVGART Hytrulo for CIDP reported in a pipeline brief) but rely on secondary reporting; verify regulatory details directly with FDA notices where possible [12].
6. Bottom line for patients and clinicians
If you or a patient asks “was a new drug approved for peripheral neuropathy in 2024–2025?” the answer from these sources is: no broad, new systemic drug labeled for general peripheral neuropathy was approved in that window; targeted approvals and device clearances relevant to neuropathic conditions occurred — notably eplontersen for ATTR‑PN becoming available in Jan 2024 (reported Dec 2023) [1], Neuralace’s Axon Therapy clearance for PDN in Jan 2024 [2] [3], and the Jan 30, 2025 approval of suzetrigine for acute pain while studies continue for neuropathy uses [4] [5]. Available sources do not mention a broader FDA approval for general peripheral neuropathy beyond these items (available sources do not mention such an approval).