A roughly $41 million Defense Department contract, two 2026 emergency declarations and a possible FDA Emergency Use Authorization for a sublingual ketamine wafer: what has happened and what has not.
The Pentagon ketamine wafer, a product called Wafermine, could reach troops before full approval through a Food and Drug Administration (FDA) Emergency Use Authorization (EUA). The Department of Defense (DoD) is paying Singapore-based iX Biopharma US$40.95 million to develop the wafer and to do the work an EUA requires. As of October 22, 2026, Military Times does not report any authorization granted, and Wafermine is not FDA-approved.
Wafermine is a small ketamine wafer that dissolves under the tongue. Two emergency declarations, one from Defense Secretary Pete Hegseth on July 15 and one from Department of Health and Human Services (HHS) Secretary Robert Kennedy Jr. on September 3, give the FDA a route to authorize unapproved medications to treat war wounds.
The Pentagon ketamine wafer could reach troops before approval if three pieces line up: a funded development program, a declared emergency, and an FDA emergency authorization. The first two pieces are in place. The third has not been reported.
The development contract came first. iX Biopharma announced the DoD award on February 12, 2026, and the money funds Phase 3 clinical development plus the activities needed to obtain an EUA for DoD use.
The emergency declarations followed. Hegseth's July 15 determination found that a military emergency exists or could develop, involving a heightened risk of chemical, biological, radiological or nuclear attack, or attacks causing life-threatening injuries. Kennedy's September 3 declaration said circumstances justify authorizing emergency use of drugs identified by the Pentagon.
The FDA authorization is the missing piece. iX Biopharma announced it is pursuing an emergency authorization, which could make the drug available to troops before full FDA approval. Military Times does not state whether a request has been filed, whether any authorization has been granted, or how long an FDA review might take.
The DoD contract is a sole-source award of US$40.95 million, made through the Defense Health Agency Contracting Activity (DHACA). Military Times rounds the figure to nearly $41 million and explains that sole-source means other vendors were not solicited. The iX Biopharma release says the government determined the company is uniquely positioned to deliver Wafermine within the required timelines.
The contract runs for a 36-month period of performance. It funds two tracks in parallel: Phase 3 clinical trials and the activities required for an EUA covering DoD use. According to the release, the DoD pays the company's labor and project costs through fixed monthly payments and cost reimbursements.
iX Biopharma, which is listed on the Singapore Exchange, calls Wafermine its patented sublingual ketamine wafer and the "world's first sublingual ketamine for acute moderate to severe pain." The company describes the product as non-opioid. Neither source states the dose, strength or exact formulation.
Ketamine is typically given by injection. With Wafermine, patients absorb the ketamine through the mucous membrane under the tongue into the bloodstream, and the release says the wafer is designed for use without injections or intravenous access.
The release also cites a positive Phase 2b post-operative pain study, long-standing supply to Australian hospitals under a regulatory exemption, and a successful End-of-Phase 2 meeting with the FDA. These are company statements. Military Times does not report independent data on the wafer's performance or safety.
Two declarations, issued 50 days apart by two departments, give the FDA a route to authorize unapproved medications for war wounds. The DoD determination came on July 15 and the HHS declaration on September 3.
Hegseth's determination describes the injuries it has in mind. The declaration says these injuries may cause moderate to severe acute pain and life-threatening hemodynamic instability, including shock or respiratory distress.
Kennedy's notice declares that circumstances justify authorizing emergency use of drugs the Pentagon identifies, but it does not elaborate on the emergency circumstances. It also does not name which drugs would be covered.
The declarations make an emergency route available. Military Times does not describe either one as naming Wafermine.
An Emergency Use Authorization is an FDA route to authorize an unapproved product during a declared emergency. It is separate from a New Drug Application (NDA), the full submission a company makes to seek FDA approval.
The iX Biopharma release describes both tracks running at the same time. The funded EUA pathway would let the DoD deploy Wafermine before full FDA approval. In parallel, the Phase 3 trials build toward eventual submission of a full NDA.
iX Biopharma's domestic manufacturing partner lacks the Nevada license required to operate, according to a Politico investigation reported by Military Times. Military Times does not name the partner.
The report also does not state the status of any remedy. It does not state the status of any remedy.
The Pentagon ketamine wafer plan does not make Wafermine an approved or authorized drug. As of October 22, 2026, Wafermine is not FDA-approved, and no EUA has been reported granted.
The plan does not change the rules for ketamine clinics, telehealth prescribing or compounded ketamine. Those rules are covered in the site's guide to whether ketamine is legal in the US and its broader ketamine guide.
Civilian use is a stated development goal only. The iX Biopharma release says Wafermine is being developed for civilian commercial use as a non-opioid pain drug, and no civilian approval is reported.
No. As of October 22, 2026, Wafermine is not approved by the Food and Drug Administration. The Department of Defense contract funds Phase 3 trials toward an eventual New Drug Application, and the sources report no such filing.
Wafermine is a small ketamine wafer that dissolves under the tongue, so the ketamine is absorbed through the mucous membrane into the bloodstream. Ketamine is typically given by injection. iX Biopharma says Wafermine is designed for use without injections or intravenous access.
No authorization has been reported. iX Biopharma announced it is pursuing an Emergency Use Authorization, but Military Times does not state whether a request has been filed or granted. Military Times gives no FDA review timeline.
iX Biopharma Ltd. is a Singapore-based company listed on the Singapore Exchange. It received a sole-source US$40.95 million Department of Defense contract, announced February 12, 2026, to develop Wafermine. The award was made through the Defense Health Agency Contracting Activity.
No. The rules for ketamine clinics, telehealth prescribing and compounded ketamine are unaffected by the contract or the emergency declarations. iX Biopharma says it is developing Wafermine for civilian commercial use, but that is a stated goal, and the wafer is not approved.
Military Times cites a 2023 study, linked to a BMJ Military Health publication, that found opioid use for battlefield injuries decreased between January 2010 and December 2019 while ketamine use increased. The study found ketamine is generally used first for more severely injured patients and increasingly serves as the military's primary analgesic for combat casualties. iX Biopharma says its wafer is designed for use without injections, which it calls relevant to battlefield and remote care.
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