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Palforzia was withdrawn from the US market on 31 July 2026 β€” a commercial decision by its manufacturer, not a safety one.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

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.

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

What Xolair does, and what it does not

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

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.

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.

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

One treatment, two ways in

If there is no food allergy clinic near you

Frequently Asked Questions

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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