What is Palforzia?: The First FDA-Approved Oral Immunotherapy for Peanut Allergy

October 5, 2025 •

3 min read

With peanut allergy being one of the most common food allergies in the U.S., affecting millions, the FDA-approved treatment Palforzia offers a new option for risk management. This oral immunotherapy helps desensitize patients, mitigating the severity of allergic reactions from accidental exposure to peanut protein.

Quick Summary

Palforzia is an oral immunotherapy containing peanut protein powder, approved to mitigate allergic reactions in peanut allergy patients aged 1-17, caused by accidental exposure.

Key Points

What is Palforzia?: Palforzia is the first FDA-approved oral immunotherapy (OIT) medication for treating peanut allergy in children and adolescents.
Mechanism of Action: It works by desensitizing the immune system to peanut protein, reducing the severity of allergic reactions from accidental exposure.
Treatment Phases: The process involves three phases—Initial Dose Escalation in a clinic, a multi-month Up-Dosing phase, and a daily Maintenance dose.
Safety Precautions: Due to the risk of anaphylaxis, Palforzia is available only through a restricted REMS program, requiring supervised dosing and access to injectable epinephrine.
Not a Cure: Palforzia does not cure a peanut allergy and requires patients to continue a peanut-avoidant diet.
Patient Profile: It is approved for patients aged 1-17 to start treatment, with maintenance continuing for older patients.
Common Side Effects: Common adverse effects include abdominal pain, itching of the mouth, and throat irritation.

Understanding What is Palforzia?

Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) is a prescription oral immunotherapy (OIT) medication for peanut allergy. It is the first and only standardized treatment of its kind approved by the U.S. Food and Drug Administration (FDA). The goal is not to cure peanut allergy but to reduce the severity of allergic reactions, including anaphylaxis, from accidental exposure to peanuts. Treatment is initiated in children aged 1 through 17 years and can be continued in patients 1 year of age and older. Palforzia is not for emergency treatment of allergic reactions and requires a strict peanut-avoidant diet.

The Science Behind Oral Immunotherapy

Oral immunotherapy involves controlled exposure to increasing amounts of an allergen, such as peanut protein in Palforzia, to retrain the immune system. This process aims to reduce the severity of reactions during accidental ingestion.

OIT influences the immune response by:

Desensitizing cells like mast cells and basophils that release allergy-related chemicals.
Promoting regulatory T-cells that help suppress allergic reactions.
Potentially lowering levels of IgE antibodies specific to peanuts.

This helps increase the amount of peanut protein a patient can tolerate, offering protection against severe reactions from accidental exposure.

The Three-Phase Palforzia Treatment Process

Palforzia treatment involves three structured phases under medical supervision.

Initial Dose Escalation

This initial phase occurs in a healthcare setting capable of managing anaphylaxis. Patients receive several increasing amounts of Palforzia over hours with observation. The amount given varies by age group.

The Up-Dosing Phase

Following the initial phase, up-dosing takes several months. Each new amount level is first given at the allergist's office. If tolerated, the patient takes this amount daily at home for two weeks before the next supervised increase, continuing until the maintenance amount is reached.

The Maintenance Phase

Patients enter the maintenance phase after up-dosing, taking a daily amount of Palforzia to maintain desensitization. Regular allergist visits are needed during this phase.

Important Safety Information and Risks

Due to the risk of severe allergic reactions, Palforzia is available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS). This program requires specific safety protocols including supervised administration of initial and first up-dosing levels, patient access to injectable epinephrine, and strict peanut avoidance. Common side effects may include stomach issues, mouth itching, throat irritation, coughing, and hives. Serious risks include anaphylaxis and eosinophilic esophagitis. Palforzia is not recommended for patients with uncontrolled asthma or a history of eosinophilic esophagitis. More information on risks and side effects can be found on {Link: PALFORZIA® FAQs & Resources https://www.palforzia.com/resources-faq/}.

Palforzia Versus Traditional Management

Comparing Palforzia to traditional peanut allergy management highlights their different approaches to risk reduction.


Feature	Palforzia (Oral Immunotherapy)	Traditional Management
Primary Goal	Mitigate severity of accidental reactions by desensitizing the immune system.	Prevent all reactions through strict dietary avoidance.
Risk of Accidental Exposure	Reduces the potential for severe reactions, offering a layer of protection and peace of mind.	Can result in a severe or life-threatening anaphylactic reaction.
Treatment Action	Active treatment involving daily, controlled exposure to peanut protein.	Passive management requiring constant vigilance and a peanut-free diet.
Epinephrine Use	Patients must still carry and be ready to use an epinephrine auto-injector.	Patients must carry and be ready to use an epinephrine auto-injector.
Side Effects	Common side effects can occur, particularly during initial phases; anaphylaxis is a risk.	Side effects are not associated with treatment itself, but from accidental exposure.
Cure	Not a cure; indefinite daily dosing required to maintain effect.	Not a cure; lifetime avoidance required.

Conclusion

Palforzia is a notable advancement for managing peanut allergies in children and adolescents. By using OIT to gradually desensitize the immune system, it provides vital protection against severe reactions from accidental peanut exposure. It is not a cure and requires a significant, long-term commitment. Due to the risk of anaphylaxis, treatment is regulated by a REMS program and must always include a peanut-avoidant diet and accessible epinephrine. Consultation with an allergist is essential to evaluate the benefits and risks of Palforzia therapy for individual patients. More information is available on the FDA website on Palforzia.

Frequently Asked Questions

No, Palforzia is not a cure for peanut allergy. It is an oral immunotherapy treatment intended to help mitigate the severity of allergic reactions from accidental exposure to peanuts.

Palforzia is an oral powder that must be emptied from a capsule or sachet and mixed with a small amount of a semi-solid food, such as yogurt, applesauce, or pudding, before being eaten.

Palforzia is approved for patients aged 1 through 17 years to initiate treatment, and maintenance can be continued for patients 1 year and older. It requires a confirmed diagnosis of peanut allergy.

The most commonly reported side effects include abdominal pain, oral itching or burning, throat irritation, coughing, wheezing, and skin reactions like hives or rash.

Yes, patients must still carry and be trained on the use of an injectable epinephrine auto-injector, as Palforzia does not treat an active allergic reaction and severe reactions can still occur.

No, Palforzia is not for the emergency treatment of allergic reactions and should not be taken during a reaction.

The PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) is a mandatory restricted program due to the risk of anaphylaxis. It ensures that patients receive the medication under strict safety protocols and are fully educated on the risks.

No, Palforzia is not approved for the initiation of treatment in adults older than 17 years. However, individuals 18 years and older can continue maintenance dosing if they started before or at age 17.