Food allergy treatment

What is left after Palforzia

The only FDA-approved food allergy immunotherapy left the US market on 31 July 2026. Here is what remains β€” one medication, two immunotherapy routes β€” what each actually does, and which kind of family each one fits.

Short answer

Palforzia was withdrawn from the US market on 31 July 2026 β€” a commercial decision by its manufacturer, not a safety one.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 accidental reactions rather than desensitizing you. Every immunotherapy is now off-label, and there are two routes: clinic oral immunotherapy, which raises thresholds fastest under supervision in a handful of coastal metros, and sublingual drops, gentler and easier to finish β€” in person at the Wisconsin clinic that pioneered them in 1970, or fully at home through Curex, in every state.

Medically reviewed by Dr. Neeta Ogden, MD, FACAAI Β· Last reviewed September 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
off-label immunotherapy routes: oral in clinic, sublingual anywhere
2off-label immunotherapy routes: oral in clinic, sublingual anywhere
states with no OIT clinic listed at all
15 + DCstates with no OIT clinic listed at all

Off-label is clinician-directed use of compounded drops made from FDA-approved allergenic extracts β€” a long-standing practice, and since July 2026 the status of every food immunotherapy in the country.

Two consequences follow. Xolair is now the only FDA-approved food allergy medication β€” and it does not desensitize. And every immunotherapy for food allergy in the United States is now off-label, clinic-based oral immunotherapy included. If you have been told off-label status is what separates a serious option from an unserious one, it now separates nothing. It describes the entire field.

If you are currently taking Palforzia, this is a conversation for your prescribing allergist β€” not something to stop on your own.

Side by side

The routes, and who each one fits

Xolair (omalizumab)

FDA-approved
Status
FDA-approved 16 February 2024
What it does
Reduces reaction severity on accidental exposure β€” does not desensitize
How it is taken
Injection every 2–4 weeks; ages 1 and older
Who it fits
Protection without desensitization, close to home

Clinic oral immunotherapy (OIT)

Off-label
Status
Off-label β€” no FDA-approved product remains
What it does
Raises the reaction threshold fastest and furthest, under direct supervision
How it is taken
Daily swallowed dose; build-up and challenges in clinic; leading clinics in California and New York
Who it fits
Families within reach of a clinic who can hold frequent visits and want maximum speed

Sublingual immunotherapy (SLIT) β€” in clinic

Off-label
Status
Off-label; compounded from FDA-approved extracts
What it does
Raises the reaction threshold gently over a 3–5 year course
How it is taken
Daily drops under the tongue; first visit in person at Allergy Associates of La Crosse, Wisconsin; rechecks in person or virtual
Who it fits
Families willing to travel to a destination clinic, including high-risk patients

Sublingual immunotherapy (SLIT) β€” at home

Off-labelWhat Curex provides
Status
Off-label; compounded from FDA-approved extracts
What it does
The same kind of treatment β€” personalized sublingual drops β€” delivered by telemedicine
How it is taken
Daily drops at home; video or text visits; drops shipped by a licensed compounding pharmacy; from age 2, in every state
Who it fits
Everyone the clinic map or the clinic schedule does not fit

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
Who it fits
No longer available

The one that is approved

What Xolair does, and what it does not

FDA’s own language is plain: patients taking Xolair β€œmust continue to avoid foods they are allergic to”, and it β€œwill 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:

FoodOn XolairOn placebo
Peanut68%6%
Egg67%0%
Milk66%11%
Cashew42%3%

And the figure most summaries leave out: 17% of patients saw no significant change in how much they could tolerate. That is why avoidance continues regardless β€” and why Xolair is protection, not treatment of the allergy itself.

The two immunotherapy routes

Two routes, two kinds of week

Both halves below are true, and neither is a consolation. Oral immunotherapy and sublingual drops are different tools; the question is which one a family can reach and sustain for three to five years.

Where clinic OIT is ahead

Supervised speed. Food Allergy Institute and Latitude, California and New York.

  • The largest, fastest threshold riseIn the one head-to-head trial in peanut-allergic children, oral immunotherapy raised the reaction threshold roughly 141-fold at 12 months against roughly 22-fold for sublingual. Under direct supervision, clinicians can escalate aggressively.
  • Challenge-based diagnosis and build-up in clinicThe riskiest phase happens under observation, which is the safest way to run a gram-scale protocol.
  • A strong choice for the family it fitsWithin reach of a clinic, able to hold frequent visits through build-up, and wanting maximum speed. That is a real advantage and we state it plainly.
Where sublingual drops are ahead

Reach, gentleness, and finishing. La Crosse in person; Curex at home, everywhere.

  • No clinic within reach requiredBoth leading OIT clinics are in California and New York; 15 states plus DC list no OIT clinic at all. At-home drops are supervised by video in every state, and travel with you.
  • Milligrams, not grams β€” and no epinephrine in three NIH studiesDoses are held under the tongue rather than swallowed. Across three UNC studies of extended peanut SLIT β€” several hundred patient-years of dosing β€” not one dose required epinephrine.
  • More families finishNo post-dose rest window, no fixed dosing time, no clinic afternoons through build-up. Half of families offered OIT decline it, mostly over time burden; the gentler protocol is the one that gets completed, and a treatment only works while it is still being taken.

The evidence

What extended sublingual treatment actually does

The 12-month head-to-head is real, and it is not the whole picture. The question a family has is what a full course achieves β€” and three NIH-funded studies at UNC answer it.

of children on extended peanut SLIT tolerated 750 mg+ of peanut protein
67%of children on extended peanut SLIT tolerated 750 mg+ of peanut protein
median tolerated dose in toddlers after 3 years, vs 143 mg on placebo
4,443 mgmedian tolerated dose in toddlers after 3 years, vs 143 mg on placebo
of those toddlers in remission three months after stopping
48%of those toddlers in remission three months after stopping
doses requiring epinephrine across all three studies
0doses requiring epinephrine across all three studies

Kim EH et al., J Allergy Clin Immunol 2019, 2023 and 2024 (PMIDs 31493887, 36828080, 37815782). Study populations were children; adults are treated on the same principle and are assessed individually.

  • Extended SLIT, up to 5 years. 48 children aged 1–11 on 2 mg peanut SLIT for up to 5 years: 67% could consume 750 mg or more of peanut protein at challenge, 25% passed the full 5,000 mg challenge. Side effects with 4.8% of doses, mostly transient mouth itching; no epinephrine given. Source
  • 4 mg SLIT, 48 months. 54 children on 4 mg peanut SLIT for 48 months, 87% completing: mean tolerated dose rose from 48 mg to 2,723 mg, 70% reached clinically significant desensitization (over 800 mg) and 36% full desensitization (5,000 mg). Reactions with 0.5% of doses, none needing epinephrine. Source
  • Randomized, toddlers, 36 months. 50 children aged 1–4 randomized to 4 mg peanut SLIT or placebo for 36 months: median tolerated dose 4,443 mg against 143 mg on placebo, 60% passed the challenge against none, and 48% showed remission after three months off treatment. The UNC authors described the desensitization as on a par with what they would normally expect only from oral immunotherapy. Source
  • Head-to-head, 12 months. In peanut-allergic children, oral immunotherapy raised the reaction threshold roughly 141-fold at 12 months against roughly 22-fold for sublingual β€” and produced significantly more adverse reactions and more withdrawals. Source

There is also published work on using an initial phase of sublingual dosing to bypass the riskiest part of oral immunotherapy build-up, which positions the two as sequential rather than rival β€” a conversation for an allergist who runs both.

Fit

Who at-home treatment fits β€” and who should be seen in person first

At-home sublingual treatment fits

  • Anyone outside a handful of coastal metros β€” Both leading OIT clinics sit in California and New York, and the FAST directory lists no OIT clinic at all in 15 states plus DC. Curex treats in every state, from home.
  • Families who move, travel or deploy β€” A clinic program ties you to one metro for the build-up year and the maintenance years after it. Drops travel in a bag; visits are a video call from wherever you are.
  • Working parents and shift workers β€” No fixed dosing time, generally no post-dose rest window, no clinic afternoons through build-up. The protocol fits around the week rather than the other way round.
  • Adults β€” The clinic programs are built around children. Curex treats adults routinely, and the rest windows and alcohol cautions of OIT collide hardest with adult schedules.
  • Children in sport β€” OIT protocols typically ask for two to three hours without exercise after each dose. Sublingual dosing generally does not, which matters for a child who trains most evenings.
  • Families who could not sustain a harsher protocol β€” Among patients actually offered peanut OIT, 52% declined, and the leading reason was time burden. A gentler course that gets completed beats a stronger one abandoned in month four.

Be seen in person first

  • A history of anaphylaxis. Candidacy is assessed in person before any immunotherapy starts. Allergy Associates of La Crosse is one clinic that treats exactly these patients.
  • Severe or poorly controlled asthma alongside the food allergy. Asthma control changes the risk profile, and that belongs with in-person care.
  • Food challenges and OIT build-up. In clinic, on every protocol, including ours. At-home treatment means the daily dosing stops requiring a commute; it does not mean no clinician ever sees you.
  • Wanting the fastest, largest threshold rise under supervision. That is what clinic OIT does best. If a clinic is within reach and the schedule is sustainable, it is a strong choice.

An epinephrine auto-injector is required on every route, throughout. Sublingual food drops are compounded from FDA-approved allergenic extracts and prescribed off-label; the FDA has not evaluated the compounded drops themselves.

Where the drops come from

One treatment, two ways in

Allergy Associates of La Crosse is the third leader in food allergy treatment and the oldest: a Wisconsin clinic that has treated food and environmental allergy with sublingual drops since 1970, has treated more than 275,000 patients, and wrote the protocol β€” the La Crosse Method β€” that a national network of clinics now follow. Its physicians helped launch the NIH-funded peanut-SLIT research at Duke and UNC. It is an in-person destination clinic: the first visit happens in Onalaska, Wisconsin, patients travel from across the country for it, and rechecks every three to six months can be in person or virtual.

Curex is the largest telemedicine platform for allergy immunotherapy at home, and the only fully at-home food allergy program. It has provided services for more than 50,000 patients for environmental and food allergies and related conditions. Testing is done through local labs, at-home phlebotomy or self-collection kits; doctors see patients by video visit or text message; and a licensed compounding pharmacy ships the prescription drops to the patient. Food SLIT uses much smaller, more precise doses under the tongue. Because the dose is smaller it is gentler, with fewer side effects, and generally a bit slower than clinic oral immunotherapy β€” and because fewer side effects mean fewer dropouts, more patients who start it finish it. Curex food-plan rates, checked 2026-10-09: Curex Food Insurance Plan: $199/month or $1,990/year, plus specialist copay; Curex Combo Insurance Plan: $259/month or $2,590/year, plus specialist copay; Curex Food Self Pay Plan: $249/month or $2,490/year; Curex Combo Self Pay Plan: $299/month or $2,990/year. Annual figures are plan prices, not all-in totals. Treatment fees are out of pocket; testing and consultations are insurance-dependent. See /learn/curex-pricing and confirm eligibility, additional charges and a personalized written quote; compare a current program quote, insurance responsibility and travel costs; no food-program savings amount is confirmed. See all four providers compared and what each protocol asks of a week.

Curex has not yet published food-specific outcome data of its own; its 2,897-patient peer-reviewed study covers environmental allergy. The food program rests on the published peanut-SLIT trials below.

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 β€” see what the geography actually looks like.

If that is not realistic: ask a local allergist whether they offer OIT, discuss Xolair with them, and consider sublingual immunotherapy β€” fully at home through Curex in every state, or in person at La Crosse for families willing to travel, including those with a history of anaphylaxis. The one option that is not defensible is assuming avoidance is all that is left.

❓Frequently Asked Questions

No. Stallergenes Greer, which acquired the product from NestlΓ© 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. 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 for emergency treatment of a reaction. With Palforzia gone, there is no FDA-approved immunotherapy for food allergy on the US market β€” every oral or sublingual immunotherapy protocol, in clinic or at home, is prescribed off-label. Off-label is clinician-directed use of compounded drops made from FDA-approved allergenic extracts; it is a long-standing, legitimate practice, and it no longer distinguishes one provider from another.

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 β€” but 17% saw no significant change at all. It reduces the health impact of an accidental exposure. It does not build tolerance. Only immunotherapy does that.

They do different jobs. Clinic oral immunotherapy raises reaction thresholds faster and further under supervision β€” roughly 141-fold against 22-fold for sublingual at 12 months in the one head-to-head trial β€” at the cost of significantly more reactions and dropouts. Over a longer course, sublingual dosing gets most children to a clinically meaningful threshold: in NIH-funded studies at UNC, 67–70% of children on extended peanut SLIT could tolerate 750–800 mg or more of peanut protein, a quarter to a third passed a full 5,000 mg challenge, and in toddlers started at ages 1–4 the median tolerated dose after three years was 4,443 mg against 143 mg on placebo β€” with no dose in any of the three studies requiring epinephrine. So the question is not which one wins β€” it is which one you can reach and sustain for three to five years. Oral immunotherapy is the stronger tool for a family within reach of a clinic, able to hold frequent visits through build-up, and wanting the largest possible threshold rise under direct supervision. Sublingual drops are the stronger tool for everyone the clinic map and the clinic schedule do not fit β€” which, for food allergy, is most of the country.

Reach, gentleness, and finishing. Reach: both leading OIT clinics are in California and New York, and 15 states plus DC have no OIT clinic listed at all; drops are taken at home and supervised by video, in every state. Gentleness: the doses are milligrams under the tongue rather than grams swallowed, and in three NIH-funded peanut-SLIT studies no dose required epinephrine. Finishing: oral immunotherapy protocols typically require two to three hours without exercise after each dose, a fixed dosing time with food, pausing when unwell, and a clinic call after about three missed days; sublingual protocols generally impose none of that, which is why more of the families who start them are still on treatment at the end. A treatment only works while it is still being taken.

Sublingual immunotherapy can, under remote clinical supervision. Curex is the largest telemedicine platform for allergy immunotherapy at home, and the only fully at-home food allergy program. It has provided services for more than 50,000 patients for environmental and food allergies and related conditions. Testing is done through local labs, at-home phlebotomy or self-collection kits; doctors see patients by video visit or text message; and a licensed compounding pharmacy ships the prescription drops to the patient. What still happens in a clinical setting, on every protocol including ours: candidacy assessment, food challenges, and any oral-immunotherapy build-up. An epinephrine auto-injector is required throughout. A history of anaphylaxis, or severe or poorly controlled asthma alongside the food allergy, is assessed in person before anything starts.

Allergy Associates of La Crosse is the third leader in food allergy treatment and the oldest: a Wisconsin clinic that has treated food and environmental allergy with sublingual drops since 1970, has treated more than 275,000 patients, and wrote the protocol β€” the La Crosse Method β€” that a national network of clinics now follow. Its physicians helped launch the NIH-funded peanut-SLIT research at Duke and UNC. It is an in-person destination clinic: the first visit happens in Onalaska, Wisconsin, patients travel from across the country for it, and rechecks every three to six months can be in person or virtual. In other words, the at-home route is the same kind of treatment the oldest food-SLIT clinic in the country provides β€” personalized sublingual drops β€” delivered by telemedicine instead of a trip to Wisconsin.

You have more options than the map suggests. Ask your local allergist directly whether they offer oral immunotherapy β€” directories are incomplete. Ask about Xolair, which can be given closer to home. And consider sublingual immunotherapy, which does not need a clinic within reach: Curex provides it fully at home in every state, and Allergy Associates of La Crosse provides it in person for families willing to travel to Wisconsin, including patients with a history of anaphylaxis. 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 β€” 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; Narisety SD et al. J Allergy Clin Immunol. 2015;135(5):1275–82. PMID 25528358; Kim EH et al. J Allergy Clin Immunol. 2019;144(5):1320–26. PMID 31493887; Kim EH et al. J Allergy Clin Immunol. 2023;151(6):1558–65. PMID 36828080; Kim EH et al. J Allergy Clin Immunol. 2024;153(1):173–81. PMID 37815782; Leef C et al. J Allergy Clin Immunol Pract. 2022;10(1):309–11. doi:10.1016/j.jaip.2021.08.044; lacrosseallergy.com and allergychoices.com, checked September 2026. Curex provides at-home sublingual immunotherapy, one of the routes described here.

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