Food Allergy Shots: Palforzia Discontinuing July 31, 2026 — What Comes Next
URGENT: Food allergy shots in the FDA-approved sense do not exist — the closest products are oral immunotherapy (Palforzia, peanut, FDA Jan 2020, COMMERCIALLY DISCONTINUING JULY 31, 2026 — 62 days away) and Xolair (omalizumab, FDA Feb 2024, 67% vs 7% peanut protection in OUtMATCH). Patients currently on Palforzia must contact their allergist before July 31, 2026. SCIT for food was abandoned after a fatal 1992 peanut trial (Oppenheimer, JACI 1992).
6 peer-reviewed sources
FDA-approved food allergy shots do not exist. Palforzia (peanut OIT) commercially discontinues July 31, 2026. Xolair (omalizumab, FDA Feb 16, 2024) provides 67% multi-food protection. Off-label OIT through specialized food-allergy clinics continues post-sunset.
The essentials
Food allergy shots in the FDA-approved sense do not exist — the closest products are oral immunotherapy (Palforzia, peanut, commercially discontinuing July 31, 2026) and Xolair (omalizumab, FDA February 2024 for food-allergy reaction prevention).
TIME-CRITICAL NOTICE — PALFORZIA COMMERCIAL SUNSET: Palforzia (peanut allergen powder-dnfp, AR101; Aimmune Therapeutics → Stallergenes Greer / Nestlé Health Science) was the only FDA-approved product for peanut allergy treatment. It is commercially discontinuing effective July 31, 2026 — 62 days from publication — as a voluntary business decision by Stallergenes Greer and Nestlé Health Science. Final new-patient starts were January 30, 2026. An estimated 5,000–7,000 US patients were on Palforzia at the time of the announcement. Patients currently on Palforzia must contact their prescribing allergist before July 31, 2026 to arrange transition pathways.
Transition options for Palforzia patients: (1) Off-label OIT continuation through specialized food-allergy clinics — the same protocol logic without Palforzia's FDA-regulated product; protocols are similar but not FDA-regulated and availability depends on clinic capacity. (2) Omalizumab (Xolair) transition — the FDA-approved alternative for food-allergy reaction prevention since February 16, 2024. (3) Xolair plus off-label OIT combination — OUtMATCH Stage 2 (NIH/NIAID, March 3, 2025) found 36% of participants on extended omalizumab tolerated ≥2 g peanut protein plus two other food allergens versus 19% on multi-allergen OIT alone (OR 2.6, P=.031), suggesting additive benefit.
Curex's at-home IgE testing with board-certified allergist review identifies whether sensitization is aeroallergen-driven (where SCIT and sublingual immunotherapy are appropriate) or food-allergen-driven (where neither is) — a necessary precondition for any treatment decision.
Why SCIT for food allergy does not exist: the seminal abandoned-peanut-SCIT trial (Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, Leung DY, JACI 1992;90:256–262) demonstrated a 13.3% systemic reaction rate, was terminated after a fatal anaphylaxis, and established that the subcutaneous route is too dangerous for food allergens. Every food-allergy treatment developed since — Palforzia, Xolair, investigational SLIT for food — is built on the lesson that the subcutaneous route does not work for food.
Xolair (omalizumab) FDA approval details: FDA approved February 16, 2024 for reduction of allergic reactions including anaphylaxis from accidental exposure to one or more foods in adults and children ≥1 year with IgE-mediated food allergy. OUtMATCH pivotal trial (Wood RA et al., NEJM 2024;390:889–899; DOI 10.1056/NEJMoa2312382): 67% of omalizumab-treated versus 7% placebo tolerated ≥600 mg peanut protein without dose-limiting symptoms after 16–20 weeks. Xolair is anti-IgE monoclonal therapy — not allergen-specific tolerance induction, not a cure. Requires repeated dosing every 2–4 weeks alongside continued food avoidance. NOT for emergency anaphylaxis treatment — epinephrine remains the rescue.
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See if at-home shots are right for youFrequently asked questions
What are food allergy shots?
In the FDA-approved sense, 'food allergy shots' do not exist as a distinct treatment category. Subcutaneous immunotherapy (SCIT) using food allergen extracts was abandoned after a fatal 1992 peanut SCIT trial (Oppenheimer JJ et al., JACI 1992). The closest FDA-approved products were: Palforzia (peanut oral immunotherapy, FDA 2020, commercially discontinuing July 31, 2026) and Xolair (omalizumab, FDA February 16, 2024 for food-allergy reaction prevention). These are fundamentally different from environmental allergy shots — Palforzia is a daily oral powder (not an injection), and Xolair is an anti-IgE monoclonal antibody injection, not an allergen extract.
What happens to Palforzia patients after July 31, 2026?
After July 31, 2026, Palforzia (the only FDA-approved peanut OIT product) will no longer be commercially available. Patients currently on Palforzia have several transition pathways to discuss with their allergist: (1) Continuing peanut OIT off-label through a specialized food-allergy clinic using a similar desensitization protocol without the FDA-regulated Palforzia product. (2) Transitioning to omalizumab (Xolair), which provides ongoing protection against accidental peanut exposure (67% threshold protection in OUtMATCH). (3) Combination Xolair plus off-label OIT. Patients should not discontinue peanut OIT abruptly — tolerance may decay over weeks after stopping, increasing anaphylaxis risk from accidental exposures.
Is Xolair a food allergy shot?
Xolair (omalizumab, Genentech/Novartis) is an anti-IgE monoclonal antibody injection — not an allergen extract immunotherapy and not a cure for food allergy. It was FDA-approved February 16, 2024 for reduction of allergic reactions including anaphylaxis from accidental food exposure in patients ≥1 year with IgE-mediated food allergy. The OUtMATCH trial (Wood RA et al., NEJM 2024;390:889–899) found 67% of treated participants versus 7% placebo tolerated ≥600 mg peanut protein. Xolair works by binding free IgE, reducing the IgE available to trigger reactions — it requires ongoing dosing every 2–4 weeks and does not produce lasting tolerance when discontinued.
Why were peanut allergy shots abandoned?
Peanut subcutaneous immunotherapy was abandoned after the 1992 trial by Oppenheimer JJ, Nelson HS, Bock SA, Christensen F, and Leung DY (JACI 1992;90:256–262). The trial showed efficacy signals but a 13.3% systemic reaction rate, and was terminated after a fatality caused by a pharmacy error in which a placebo patient received a maintenance peanut dose. A second confirmatory study (Nelson 1997) reported systemic reaction rates of 13.3–39%. The field concluded that food allergens delivered subcutaneously are too concentrated relative to aeroallergens, triggering immediate IgE-mediated reactions at the doses required for meaningful desensitization.
Can I get food allergy shots at a regular allergist?
No. Regular allergist offices administer subcutaneous immunotherapy (SCIT) using FDA-licensed aeroallergen extracts — grass, ragweed, dust mite, cat, and similar environmental allergens. Food allergen SCIT does not exist as an FDA-approved product, and no FDA-licensed US manufacturer (Greer, ALK-Abelló, Stallergenes Greer) produces food allergen SCIT extracts. Food-allergy patients who are interested in oral immunotherapy (OIT) — the evidence-based treatment approach — should seek out specialized food-allergy OIT clinics, which exist at academic medical centers and some private practices. Xolair (omalizumab) for food allergy is prescribed by allergists and administered in an office setting with a 30-minute observation period per FDA labeling.
What is the evidence for Xolair in food allergy?
The OUtMATCH trial (Wood RA, et al., NEJM 2024;390:889–899; DOI 10.1056/NEJMoa2312382) was the pivotal study supporting Xolair's FDA approval for food allergy in February 2024. In the stage 1 results, 67% of omalizumab-treated participants versus 7% placebo tolerated ≥600 mg peanut protein without dose-limiting symptoms after 16–20 weeks of treatment. OUtMATCH Stage 2 (NIH/NIAID, reported March 3, 2025) found that 36% of participants on extended omalizumab tolerated ≥2 g peanut protein plus two other food allergens versus 19% on multi-allergen OIT (OR 2.6, P=.031). Xolair provides protection against accidental exposures but does not eliminate food allergy, and protection may diminish when omalizumab is discontinued.
Are there any clinical trials for food allergy shots?
There are no active clinical trials for subcutaneous food allergen immunotherapy (SCIT) in the US — the approach was definitively abandoned after the 1992 peanut trial fatality. Current food-allergy immunology research focuses on oral immunotherapy (OIT), epicutaneous immunotherapy (EPIT — Viaskin peanut patch, DBV Technologies), sublingual immunotherapy for food (investigational), and combination approaches with omalizumab. The NIH/NIAID Consortium for Food Allergy Research (CoFAR) and ClinicalTrials.gov are the appropriate registries for patients interested in research-stage food-allergy interventions. Xolair-plus-OIT combination protocols are actively studied, with OUtMATCH Stage 2 results published in 2025.
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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.