What is left after Palforzia
The only FDA-approved food allergy immunotherapy left the US market on 31 July 2026. Here is what that changes, and what each remaining route actually does — including where the option we provide is not the strongest one.
Palforzia was withdrawn from the US market on 31 July 2026 — a commercial decision by its manufacturer, not a safety one. That leaves Xolair as the only FDA-approved food allergy medication, and Xolair reduces the severity of reactions to accidental exposure rather than desensitizing you. Every immunotherapy for food allergy in the United States is now off-label: clinic-based OIT raises reaction thresholds the most, sublingual drops raise them less but cause far fewer reactions.
Medically reviewed by Dr. Chet Tharpe, M.D. · Last reviewed August 2026
What changed
The only approved immunotherapy is gone
Palforzia was approved on 31 January 2020 and extended to children aged 1–3 by an FDA supplement approval dated 26 July 2024. Stallergenes Greer then discontinued it worldwide, and it left the US market on 31 July 2026. The company stated the decision was not related to the product’s safety, quality or efficacy, citing complex administrative and dosing requirements that had limited its adoption.
- FDA-approved food allergy medication left: Xolair
- 1FDA-approved food allergy medication left: Xolair
- FDA-approved food immunotherapies on the US market
- 0FDA-approved food immunotherapies on the US market
- reaction threshold increase on OIT at 12 months
- 141×reaction threshold increase on OIT at 12 months
- reaction threshold increase on SLIT at 12 months
- 22×reaction threshold increase on SLIT at 12 months
Threshold figures come from a randomized head-to-head comparison in peanut-allergic children (PMID 25528358). Every route still requires an epinephrine auto-injector.
Two consequences follow, and they matter more than the headline. Xolair is now the only FDA-approved food allergy medication — and it does not desensitize. And every immunotherapy for food allergy in the United States is now off-label, not just sublingual drops but clinic-based oral immunotherapy too.
That second point is worth sitting with if you have been told off-label status is what separates a serious option from an unserious one. As of today it separates nothing. It describes the entire field.
If you are currently taking Palforzia, this is a conversation for your prescribing allergist — not something to stop on your own.
Side by side
The four routes
Xolair (omalizumab)
FDA-approved- Status
- FDA-approved 16 February 2024
- What it does
- Reduces reaction severity on accidental exposure — does not desensitize
- How it is taken
- Injection every 2–4 weeks
- Ages
- 1 and older
Clinic-based OIT
Off-label- Status
- Off-label — no FDA-approved product remains
- What it does
- Raises the reaction threshold — the largest effect of the three
- How it is taken
- Daily food or protein dose; build-up and challenges in clinic
- Ages
- Varies by centre
Sublingual immunotherapy (SLIT)
Off-labelWhat Curex provides- Status
- Off-label; compounded, not FDA-evaluated
- What it does
- Raises the reaction threshold — smaller effect than OIT
- How it is taken
- Daily drops under the tongue, at home
- Ages
- From 2 at Curex
Palforzia (peanut OIT)
No longer available- Status
- Withdrawn from the US market 31 July 2026
- What it does
- Raised the peanut reaction threshold
- How it is taken
- Daily oral powder; build-up supervised in clinic
- Ages
- Was 1–17
The one that is approved
What Xolair does, and what it does not
FDA’s own language is unusually plain: patients taking Xolair “must continue to avoid foods they are allergic to”, and it “will not eliminate food allergies or allow patients to consume food allergens freely”. It reduces the health impact of an accidental exposure. It does not build tolerance, and it is not for treating a reaction in progress.
In the pivotal trial of 168 patients, tolerating at least 600 mg of food protein:
| Food | On Xolair | On placebo |
|---|---|---|
| Peanut | 68% | 6% |
| Egg | 67% | 0% |
| Milk | 66% | 11% |
| Cashew | 42% | 3% |
And the figure most summaries leave out: 17% of patients saw no significant change in how much they could tolerate. That is precisely why avoidance continues regardless of treatment.
The head-to-head
OIT is more effective. Drops are easier to finish.
Both halves of that sentence are supported, and leaving either one out would be misleading — including the half that does not favour us.
Stated plainly — this is the option we do not provide.
- Much larger threshold increaseIn a direct comparison in peanut-allergic children, oral immunotherapy produced roughly a 141-fold increase in reaction threshold at 12 months, against roughly 22-fold for sublingual.
- An FDA-approved product existsPalforzia is approved for peanut, ages 1–17. No sublingual food product has FDA approval; drops are compounded and off-label.
- Supervised build-upDoses are escalated under clinical observation, which is the safer way to handle the riskiest phase.
Sustainability, not potency.
- Markedly fewer adverse reactionsThe same head-to-head found OIT associated with significantly more adverse reactions and more early withdrawals.
- Fits an ordinary weekOIT protocols typically require two to three hours without exercise or a hot shower after each dose, dosing at a fixed time with food in the stomach, pausing while unwell, and a call to the clinic after about three missed days. Sublingual protocols generally do not impose a rest period — confirm the specifics with your own prescriber.
- Possible on-ramp to OITEmerging evidence suggests 1–2 years of sublingual dosing may be a safe way to bypass the riskiest phase of OIT build-up — sequential rather than rival.
The honest summary: a course that gets finished at a smaller effect size can beat a larger one abandoned in month four. That is the trade, and which side of it suits you depends on your family, not on which company you ask.
Unchanged by any of it
What every route requires
- An epinephrine auto-injector, on every route, throughout treatment.
- In-clinic supervision for food challenges and OIT build-up. These are not home procedures on any protocol.
- Careful assessment where there is a history of anaphylaxis before starting anything at all.
- In-person management where severe or poorly controlled asthma sits alongside the food allergy.
Access
If there is no food allergy clinic near you
The established oral immunotherapy centres are concentrated in a handful of metro areas, mostly in California and New York. For most of the country, reaching one means travel, time off, and repeat visits over years.
If that is not realistic, the honest options are to ask a local allergist whether they offer OIT, to discuss Xolair with them, or to consider sublingual immunotherapy, which can be supervised remotely. The option that is not defensible is assuming avoidance is the only thing left — see which parts of allergy care transfer to remote treatment.
❓Frequently Asked Questions
No. Stallergenes Greer, which acquired the product from Nestlé Health Science, voluntarily discontinued Palforzia worldwide, and it left the US market on 31 July 2026. The company stated the decision was not related to the product’s safety, quality or efficacy, citing instead that complex administrative and dosing requirements had limited its adoption in clinical practice. The associated FDA risk management (REMS) programme is being wound down following the withdrawal. If you are currently on Palforzia, this is a conversation to have with your prescribing allergist rather than something to stop on your own.
One medication: Xolair (omalizumab), approved on 16 February 2024 for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods, in patients aged 1 year and older with IgE-mediated food allergy. It is used together with continued food avoidance and is not indicated for emergency treatment of a reaction. With Palforzia gone, there is no FDA-approved immunotherapy for food allergy on the US market at all — every oral or sublingual immunotherapy protocol is now off-label.
No, and this is the most commonly misunderstood point. FDA is explicit that patients taking Xolair must continue to avoid the foods they are allergic to, and that it will not allow patients to consume allergens freely. In the pivotal trial, 68% of patients on Xolair tolerated at least 600 mg of peanut protein against 6% on placebo — but 17% saw no significant change at all. It reduces the health impact of an accidental exposure. It does not build tolerance.
Yes, on threshold. In a direct comparison in peanut-allergic children, oral immunotherapy produced roughly a 141-fold increase in the reaction threshold after 12 months, while sublingual immunotherapy produced roughly a 22-fold increase. Both are meaningful; OIT is substantially larger. The trade-off is that OIT was associated with significantly more adverse reactions and more people dropping out. Anyone claiming drops outperform OIT on effectiveness is misreading the evidence.
Because effectiveness on paper is not the only thing that decides whether a treatment works in a real family. Sublingual dosing has a markedly better safety profile, and it is easier to sustain. Oral immunotherapy protocols typically require two to three hours without exercise or a hot shower after each dose, pausing when the patient is unwell, dosing at the same time daily with food in the stomach, and a call to the clinic after roughly three missed days. Sublingual protocols generally do not impose a pre- or post-dose rest period, though the specifics belong to whoever writes your protocol. A course that gets completed at a smaller effect size can beat a larger one that gets abandoned in month four.
Not the first step, and not for everyone. Oral immunotherapy build-up and food challenges require in-clinic supervision because of the risk of a systemic reaction. Xolair is an injection given every two to four weeks. Sublingual drops are taken at home, but candidacy still has to be assessed by a clinician, an epinephrine auto-injector is required, and a history of anaphylaxis calls for careful evaluation before starting anything. Anyone with severe or poorly controlled asthma alongside a food allergy should be managed in person.
That is the practical reality for most of the country — the established oral immunotherapy centres are concentrated in a handful of metro areas, mainly in California and New York. If travelling to one is not realistic, the honest options are to ask a local allergist whether they offer OIT, to discuss Xolair with them, or to consider sublingual immunotherapy, which can be supervised remotely. What is not a good option is doing nothing on the assumption that avoidance is the only alternative.
If you experience sudden difficulty breathing, throat swelling, or other signs of anaphylaxis, call 911. A prescribed epinephrine auto-injector is the first-line treatment — not antihistamines.
This content is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider with questions about a medical condition. Content reviewed by board-certified allergists at Curex.
Sources: FDA approval and prescribing information for Xolair (16 February 2024); FDA approval of Palforzia (31 January 2020) and the supplement approval extending it to ages 1–3 (26 July 2024); the manufacturer’s withdrawal notice and the wind-down of the Palforzia REMS programme; randomized comparison of sublingual versus oral immunotherapy for peanut allergy (PMID 25528358). Curex provides sublingual immunotherapy, one of the routes described here.
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