RecoveryRx · in clinical partnership with Biostax Corp · Lodonal®

Trans-forming health
by restoring the system
the body was built to use.

RecoveryRx is the immune-restoration telehealth company built on Lodonal® — a precision low-dose naltrexone therapy — in clinical-development partnership with Biostax Corp. One molecule. Six pathways. Sixteen indications. Treating the chronic inflammation that drives Long COVID, autoimmune disease, chronic pain, PTSD, cancer-adjunctive care, and addiction recovery — together, not in silos.

200K+
Patient exposures · 60+ trials · 75 peer-reviewed references
16
Indications across inflammatory, immune, neuro, metabolic & oncology
40+
Years of validated low-dose naltrexone clinical safety data
0
Serious adverse events · non-addictive · non-immunosuppressive
A note from the platform
Modern medicine treats the body in pieces. The gastroenterologist treats one organ. The psychiatrist, another. The pain specialist, a third. But chronic illness does not respect those borders.

Depression in Crohn's is driven by cytokines. Anxiety in Long COVID arises from autonomic and mitochondrial collapse. Pain fuels trauma, and trauma amplifies inflammation. These are not separate diseases — they are one system, dysregulated.

RecoveryRx exists because the body's recovery cannot be suppressed into being. It must be restored.
00 — About RecoveryRx

The company built to break the loop.

RecoveryRx is the immune-restoration telehealth company built to treat the biological roots of chronic illness — not the symptoms a body produces once its signaling systems begin to fail.

We go beyond traditional telehealth. We deliver a unified clinical platform that restores immune function, alleviates chronic pain, supports mental health, and adapts to each patient in real time through intelligent digital monitoring.

Our care is built on Lodonal® — a patented, pharmaceutical-grade low-dose naltrexone immune modulator developed by our clinical-development partner, Attune Biotech Inc. (formerly Biostax Corporation). Lodonal acts on the upstream signaling pathways — TLR4, OGF–OGFr, glial activation, and the mitochondrial-immune axis — that drive Long COVID, autoimmune disease, chronic pain, post-traumatic stress, and the conditions of post-viral and post-treatment immune exhaustion.

Lodonal is paired with STARR, Attune Biotech's digital health companion platform — integrating AI-driven biometric monitoring, validated mental-health measurement, and evidence-based stress regulation tools field-validated in healthcare, military, and educational settings.

We do not treat isolated symptoms. We interrupt the self-perpetuating cycle that defines chronic disease: stress → inflammation → pain → immune dysfunction → mental-health decline.

Our approach combines biological precision, psychological insight, and digital engagement to restore health and resilience from the inside out.

Backed by federal partnerships, the active IND portfolio held by Attune Biotech, and a multidisciplinary clinical network licensed across all 50 states, RecoveryRx delivers scalable, non-addictive, biologically intelligent care to the high-need populations failed by fragmented chronic-care delivery — across Long COVID, HIV immune non-responders, chronic pain, PTSD, autoimmune disease, and beyond.

— Mission

To restore human resilience by addressing the root causes of chronic illness — delivering integrated, non-suppressive therapies that heal the immune system, relieve suffering, and empower mental and physical recovery, at the scale and accessibility that modern telehealth enables.

— Vision

To lead a global transformation in chronic-disease care through a unified delivery model that fuses precision immunotherapy with continuous digital monitoring — replacing the fragmented, symptom-suppressive, specialty-by-specialty status quo with biologically intelligent, person-centered care.

01 — The pharmacology

An old molecule. A new understanding.

Naltrexone has been an FDA-approved opioid receptor antagonist since 1984. What changed everything was the discovery — by Dr. Bernard Bihari in the mid-1980s — that a fraction of the dose produces an entirely different, opposite effect: not blockade, but restoration.

How a receptor antagonist becomes an immune modulator.

Naltrexone is a competitive antagonist at the µ-, κ-, and δ-opioid receptors. At the standard 50–100 mg dose, it produces sustained 24-hour blockade — the basis for its use in alcohol and opioid use disorder, where blocking reward signaling extinguishes the drive to drink or use.

At low doses (1–5 mg), the math inverts. The receptor blockade lasts only 3–6 hours. During that brief window, the body senses the loss and compensates: production of endogenous opioid peptides — β-endorphin, met-enkephalin, opioid growth factor — surges. Receptors upregulate by 87%. When the naltrexone clears, the body's own healing chemistry finds an immune system newly primed to listen.

The first two days, you'd never know it was working. By week six, patients report the loop they'd lived inside has gone quiet.

Beyond the opioid system, naltrexone is also a Toll-like receptor 4 (TLR4) antagonist. TLR4 is the brain's and gut's primary inflammatory alarm. When naltrexone binds it, microglial activation drops. IL-6, TNF-α, and nitric oxide production fall. Macrophage and T-lymphocyte activity calms. Regulatory T-cells expand. NK cells regain surveillance capacity. The immune system returns to something a healthy version of you would recognize.

Lodonal® is the standardized, GMP-manufactured, patent-protected pharmaceutical form of low-dose naltrexone — built to deliver this biology with the consistency that compounded LDN cannot.

02 — The problem

The inflammatory loop we keep losing patients to.

More than 100 million Americans live with conditions rooted in immune dysregulation and chronic inflammation. Most are treated as if they are unrelated. They are not.

10M+
Americans with Long COVID and persistent immune dysfunction
50M+
Living with autoimmune conditions — overactive, misdirected immunity
6.8M
U.S. veterans with overlapping inflammatory disease — costing $119–195B annually
30%
Of treatment-resistant depression cases linked to chronic inflammation
The self-perpetuating cycle

Inflammation drives the very symptoms that drive more inflammation.

Chronic cytokine elevation (IL-6, TNF-α, CRP) crosses the blood-brain barrier, activates microglia, and produces brain fog, fatigue, and mood collapse — which themselves provoke more inflammation through stress, sleep loss, and metabolic disruption.

High-CRP patients show 70% SSRI resistance. PTSD and chronic pain activate identical neuroinflammatory pathways. Treating only the symptom guarantees the loop continues.

The only way out is to interrupt the loop at its biology.

03 — How Lodonal works

Six pathways. One molecule. One daily capsule.

Lodonal® is not an immunosuppressant. It is a precision immune modulator. It works through six complementary mechanisms — each validated in clinical trials, each pulling the body toward equilibrium.

01
β-end

Opioid Receptor Modulation

Brief receptor blockade triggers a 43% rebound in β-endorphin. Multi-modal pain relief — non-addictive, no tolerance.

67% reduction in opioid use
02

TLR4 / TLR9 Antagonism

Suppresses the primary innate-immune alarm. Reduces IL-6, TNF-α, IL-1β, and CRP at the source — preserves host defense.

35–45% inflammatory marker reduction
03

Glial Cell Modulation

Calms activated microglia and astrocytes. Lifts brain fog, mood collapse, and central pain sensitization.

Neuroinflammation, restored
04

Mitochondrial Restoration

112% increase in cellular ATP. Complex I activity ↑142%. mtDNA copy number ↑140%. Genuine cellular energy recovery.

The fuel for everything else
05
Treg

T-Reg & NK Cell Enhancement

Increases regulatory T-cells by ~60%. NK and CD8+ surveillance up 50–70%. Immune system distinguishes self from threat.

Tolerance restored, not blunted
06

DAMP Signal Suppression

Reduces danger-associated molecular patterns released by stressed tissue. Calms the chronic alarm that perpetuates the cycle.

79% autoantibody clearance
04 — The dosing spectrum

Same molecule. Different dose, different medicine.

Naltrexone is one of the rare drugs whose biology genuinely depends on the dose. Lodonal occupies the low-dose territory — where the molecule's anti-inflammatory and immune-modulating effects emerge — not the standard 50–100 mg used to extinguish opioid or alcohol reward.

The four tiers below summarize the clinical pharmacology of the broader naltrexone family, adapted from Toljan et al. (2018). Lodonal's six standardized GMP strengths span 0.05 mg through 5 mg — the full therapeutic window for immune restoration.

Tier 01
50–100 mg
Standard dose
Sustained 24-hour µ-, κ-, δ-opioid receptor antagonism.
Approved for alcohol use disorder and opioid dependence — by extinguishing reward signaling. Outside Lodonal's scope.
Lodonal Tier 02
1–5 mg
Low dose (LDN)
TLR4 antagonism + endogenous opioid rebound. Immune modulation.
Fibromyalgia, MS, Crohn's, autoimmune disease, chronic pain, Long COVID, PTSD, cancer-adjunctive care, Hailey-Hailey, CRPS, and more.
Tier 03
0.001–1 mg
Very low dose
Same mechanism as LDN, attenuated.
Adjunct to methadone detoxification taper. Used in select pediatric and highly sensitive populations.
Tier 04
<0.001 mg
Ultra-low dose
Filamin A binding · Gs-coupling reduction at µ-receptor.
Potentiates opioid analgesia. Research and pain-management settings. Outside Lodonal's commercial scope.
Why dose matters: Continuous high-dose administration abolishes the biphasic immune effect entirely. The brief, intermittent receptor blockade of LDN is what permits the compensatory β-endorphin rebound to occur — and that rebound is the medicine.

Lodonal® ships in six standardized GMP strengths.

0.05 mg 1 mg 1.5 mg 3 mg 4.5 mg 5 mg

0.05 mg is the very-low-dose starter for highly sensitive populations (fibromyalgia, EDS / MCAS, post-viral, chronic Lyme). 1–5 mg spans the primary LDN therapeutic window across inflammatory, autoimmune, neuro-immune, metabolic, and oncology-adjunctive indications. Manufactured under U.S. cGMP at SPG Pharma / Aveva (FEI 783982093).

05 — What restoration looks like

Measurable. Across every system.

These are not isolated wins. They are the pattern of a body coming back online — observed across nearly 200 catalogued studies, spanning inflammatory, immune, neurologic, metabolic, behavioral, and functional domains.

Twenty-four biomarker signals across six categories, drawn from Phase 2 trials, VA and DoD real-world cohorts, FDA-validated endpoints, mechanistic studies, and international regulatory programs.

— I
Inflammation markers
The cytokine and acute-phase signals that drive the chronic inflammatory loop. Suppressed at the source — not blunted.
Interleukin-6
up to 30%
Cytokine driver of fatigue, depression, and treatment-resistant illness.
TNF-α
up to 25%
Tumor Necrosis Factor — central to PTSD, IBD, and pain sensitization.
IL-1β
up to 20%
Reduced sickness-behavior signaling and inflammatory pain transmission.
C-Reactive Protein
30–65%
Systemic inflammation marker — sustained reductions across Long COVID, IBD, and PTSD cohorts.
— II
Immune cell restoration
T-cells, NK cells, and the regulators that hold the line between self and threat — strengthened, not suppressed.
NK Cell Function
30–40%
TRPM3 functional restoration in Long COVID. Antiviral surveillance regained.
CD4 T-Cells
up to 44%
HIV immune restoration in non-responders on stable ART. CD4/CD8 ratio normalization.
Regulatory T-Cells
~60%
The immune system's regulators — restoring tolerance, not suppression.
T-Cell Exhaustion
65%
PD-1, TIM-3, LAG-3 reduction — same checkpoints targeted by checkpoint-inhibitor immunotherapy.
— III
Pain & neuroinflammation
Central sensitization unwound. Chronic alarm calmed. Endogenous analgesic systems brought back online.
Neuropathic Pain
up to 50%
Validated reduction in nociceptive pain measures across chronic pain cohorts.
Fibromyalgia Pain
up to 30%
Brief Pain Inventory scores. Reduced central sensitization via TLR4 modulation.
Hyperalgesia
up to 40%
Pain amplification reduction. Higher mechanical and thermal pain thresholds.
β-Endorphin
43%
Endogenous opioid system reset. Multi-modal pain relief without addiction risk.
— IV
Energy, fatigue & function
Mitochondrial recovery is the substrate of every other system's return. Energy precedes function.
Fatigue Severity
up to 52%
Improvements in energy and exertional tolerance across PASC and ME/CFS cohorts.
Post-Exertional Malaise
up to 40%
The signature ME/CFS and Long COVID exertion-crash signal — reduced.
Mitochondrial ATP
112%
Cellular energy currency. Complex I activity ↑142%, mtDNA copy number ↑140%.
Klotho-FGF21 Axis
168%
The longevity pathway — same target as Novo Nordisk's $5.2B Akero acquisition, activated endogenously.
— V
Cognition & mental health
The brain is an immune organ. When inflammation falls, cognition, mood, and sleep architecture follow.
MoCA Cognition Score
2–6 pt
Clinically meaningful gains in executive function, memory, and brain-fog clearance.
Mental Health QoL
up to 35%
SF-36 mental component summary improvement — reduced neuropsychological symptom burden.
Sleep Quality
up to 40%
Reduced sleep disturbance. Restorative architecture returning across PASC, PTSD, fibromyalgia.
Suicidal Ideation
158%
Relative improvement in DoD/military cohort. The most urgent endpoint, moved.
— VI
Disease-specific & outcomes
Where the biology becomes a clinical milestone — endoscopic healing, seizure control, recovery trajectory.
CDAI Improvement
up to 88%
Crohn's Disease Activity Index improvement rates in Phase 2 RCT.
Mucosal Healing
up to 78%
Endoscopic and histologic healing in IBD cohorts. Genuine epithelial recovery.
Seizure Frequency
80–90%
Pediatric intractable epilepsy — adjunct to anticonvulsants. EEG normalization observed.
Functional Recovery HR
5.04×
VA Long COVID cohort — hazard ratio for functional improvement vs untreated controls.
06 — One biology, many names

Conditions we treat together.

Treat the shared biology, and a dozen named diseases begin to move at once. This is not multi-indication theater. It is the consequence of treating cause, not category.

— 06.01

Inflammatory & autoimmune

Where the immune system has lost the line between self and threat. Lodonal restores tolerance via Treg expansion and TLR4 modulation — without the broad immunosuppression that defines the standard of care.

~1.6M U.S. adults & children

Inflammatory Bowel Disease (Crohn's, UC)

Phase 2 RCT showed 88% achieved ≥70-pt CDAI decline vs 40% placebo. Endoscopic and histologic mucosal healing confirmed. Pediatric Crohn's: 67% achieved disease-activity improvement.

↓ ER stress · ↑ epithelial repair
~150K–200K U.S. cases · Orphan

Autoimmune Hepatitis

First-in-class steroid-sparing candidate. FDA Orphan Drug Designation. ALT/AST and IgG normalization observed without chronic corticosteroid burden — the standard unchanged for 50 years.

Phase 2b/3 ready · IND active
1.5M U.S.

Rheumatoid Arthritis

Norwegian study of 360 patients showed reduced DMARD and opioid use on LDN. Reduced disease activity (DAS28) correlated with inflammatory marker decline.

↓ DMARD requirements
~1M U.S.

Multiple Sclerosis

Penn State Hershey retrospective (n=215): 75% reported good-to-slight fatigue benefit, 52% MRI stability. Cree et al. RCT: significant Mental Health Composite improvement vs placebo.

Safe with DMTs · 818-day mean duration
200K U.S.

Lupus & Sjögren's

Adjunct therapy for systemic lupus and Sjögren's — reduces fatigue, CRP, ESR, and pruritus. Steroid-sparing effects with preserved infection defense.

Adjunct, not replacement
14M U.S. (subclinical)

Hashimoto's Thyroiditis

Reduces autoimmune attack on thyroid tissue. Monitor TSH/FT4 closely as patients on levothyroxine may need dose reduction. ↓ TPO antibodies in observational series.

↓ TPO antibodies
1M U.S.

Psoriatic Arthritis & Scleroderma

Reduced PASI scores in psoriasis cohorts. Improved GI tolerance scores in systemic sclerosis. Effective post-biologic in hidradenitis suppurativa.

↓ pruritus · ↑ QoL
— 06.02

Chronic pain & neurological

Where central sensitization has converted real injury into permanent alarm. Lodonal calms the microglia and restores endorphin tone — without the addiction, tolerance, or cognitive cost of opioids.

~6M U.S. adults

Fibromyalgia

Marcus et al. observational (n=41): mean pain reduction of 5.15 points on Brief Pain Inventory (p<0.01). Improved mood and energy. Discontinuation rate <6%.

7 published trials · TLR4-mediated
200K U.S. cases

Complex Regional Pain Syndrome (CRPS)

Glial-cell inhibition reduces central sensitization in CRPS. Shown effective for treatment-resistant cases where standard analgesics, sympathetic blocks, and ketamine have failed.

Glial-driven sensitization
50M+ U.S. adults

Chronic Pain Syndromes

Neuropathic pain, post-surgical chronic pain, and treatment-resistant inflammatory pain. Multi-modal relief via β-endorphin reset + TLR4 antagonism. 67% reduction in opioid requirements observed.

↓ opioid use 67% · ↓ ER visits 70%
Rare orphan

Hailey-Hailey Disease

Benign familial chronic pemphigus — a debilitating skin disease for which low-dose naltrexone has emerged as one of the few effective treatments. Off-label utilization documented.

Pemphigus-family modulation
100K+ U.S.

Ehlers-Danlos & MCAS

Mast cell stabilization reduces histamine and tryptase release in EDS/MCAS cohorts. Particularly valuable where standard antihistamines and stabilizers fail. Start low, titrate slowly.

Mast cell stabilization
1M+ U.S.

ME/CFS & Post-Viral Fatigue

Mitochondrial restoration (ATP +112%, Complex I +142%) directly addresses the energy collapse defining ME/CFS. Functional improvements in 58% of patients across post-viral cohorts.

↓ post-exertional malaise
— 06.03

Mental health & trauma

Where the immune system and the nervous system are the same system. Cytokines do not merely correlate with mood — they cause it.

12M U.S. veterans & civilians

PTSD & TBI

DOD military trial: 82% sustained recovery vs 24% standard of care. Reduced startle response, improved sleep architecture, autonomic regulation, memory. Career progression +112%.

158% ↓ suicidal ideation
8M U.S.

Treatment-Resistant Depression

High-CRP patients show 70% SSRI resistance — depression that cannot be treated without addressing inflammation. Lodonal targets the root cause where antidepressants don't.

For inflammatory phenotype
40M U.S. adults

Anxiety with Inflammation

Anxiety arising from autonomic dysfunction, mitochondrial collapse, or post-viral inflammation responds where SSRIs do not. Particularly relevant in Long COVID and post-EBV cohorts.

Cytokine-driven phenotype
— 06.04

Post-viral & immune

Where infection resolved but inflammation never did. Long COVID, post-EBV, post-influenza, and HIV immune-non-responder syndromes share a single signature: persistent immune activation in the absence of acute threat.

10M+ U.S.

Long COVID (PASC)

FDA Emergency Use Authorization filed under IND 181314 + Fast Track. Military trial: cognitive function +94%, physical performance +92%, return-to-duty 82%, T-cell exhaustion ↓65%.

EUA filed · DOD-validated
~30K immunologic non-responders

HIV Immune Non-Responders

Patients on stable ART with persistent CD4+ <200. Lodonal restores CD4/CD8 ratios and reduces sCD14 chronic inflammation. Approved for HIV immune maintenance outside the U.S.

Approved internationally · NAFDAC
Multi-million

Post-EBV & Post-Influenza

Persistent immune activation following viral illness — fatigue, cognitive symptoms, exercise intolerance — responds to the same restoration mechanisms validated in PASC.

Mitochondrial recovery primary
— 06.05

Metabolic & hepatic

Where chronic inflammation has made the liver and metabolism stop listening. The 10 mg and 35 mg Lodonal protocols address the advanced end of this spectrum.

~1.5–6.5% of U.S. adults

MASH / NASH

Biostax Phase 2 program (IND 147347): ALT ↓18.3 U/L, MRI-PDFF ↓18% hepatic fat fraction, fibrosis stabilization. Mitochondrial markers (Complex I, NAD+/NADH, PGC-1α) restored.

IND 147347 · Phase 2 active
~30% of U.S. adults

MASLD / NAFLD

Most common chronic liver disease. 30% prevalence in VA enrolled population. Lodonal addresses HOMA-IR insulin resistance, hepatic CRP, and inflammatory markers driving progression.

IND 146955 · 2.7M veterans affected
42M+ U.S.

Type 2 Diabetes (inflammatory)

For the inflammatory phenotype of T2DM where insulin resistance is cytokine-driven. Klotho-FGF21 activation enhances insulin sensitivity through endogenous upregulation.

Adjunct · inflammatory subtype
— 06.06

Oncology adjunctive care

Lodonal does not replace cancer treatment. It restores the immune and mitochondrial substrate that conventional therapy depletes — and may directly inhibit growth via the OGF-OGFr axis.

2M new U.S. diagnoses/yr

Cancer-Adjunctive Immune Recovery

Hematologic malignancy RCT (n=89, 5 mo): improved physical/social/role functioning, weight maintenance, reduced nausea and appetite loss. NK and CD8+ recovery without checkpoint conflict.

75 references · 200K+ exposures
Refractory cancer pain

Cancer-Related Pain

MD Anderson Cancer Center series demonstrated 80% response rate in refractory cancer pain, including treatment-related neuropathy. Synergistic with cisplatin (3-fold apoptosis increase).

80% pain response · refractory
Multi-cancer survival cases

OGF-OGFr Growth Inhibition

87% increase in OGFr expression. 40–60% reduction in DNA synthesis in cancer cell lines. Long-term survival cases documented in HCC, glioblastoma, RCC, and pancreatic cancer with metastases.

Penn State · 300+ publications
— 06.07

Pediatric indications

Children carry the same biology, more sensitively. Pediatric protocols use weight-based dosing (0.1–0.5 mg/kg/day, max 5 mg) with slower titration.

~1 in 36 U.S. children

Autism Spectrum Disorder

Multiple RCTs and open-label studies. Reduced hyperactivity, irritability, self-mutilation, stereotypy. Improved social responsiveness and communication. Immune normalization (CD4/CD8 ratio).

↑ β-endorphin · ↑ POMC normalization
~30% of pediatric epilepsy

Intractable Pediatric Epilepsy

Egypt pediatric study: reduced seizure frequency and EEG normalization at 1–3 mg/day as adjunct to standard anticonvulsants. Mechanism: TLR4 and microglial modulation.

Adjunct to AEDs
~15K U.S. pediatric Crohn's

Pediatric Crohn's Disease

Phase 2 pilot (n=12): PCDAI scores decreased 34.2 → 21.7 (p=0.005). 25% achieved remission with histologic healing. Steroid-sparing — critical for growing children.

Steroid-sparing · growth-protective
— 06.08

Dermatologic indications

The skin is an immune organ. Most chronic dermatologic disease is an inflammatory loop with a visible signature. Lodonal acts on the underlying biology — reducing scaling, pruritus, and lesion recurrence.

7.5M U.S.

Psoriasis & Psoriatic Arthritis

Reduced PASI scores, scaling, and pruritus in clinical reviews. Particularly relevant in psoriasis with comorbid metabolic or autoimmune disease where biologics carry infection risk.

↓ PASI · ↓ pruritus
1% of U.S. population

Hidradenitis Suppurativa

Reduced nodule count and lesion recurrence. Effective in patients post-biologic therapy (TNF-α blockers) where treatment options have narrowed. Patient quality-of-life gains documented.

Effective post-biologic
~31M U.S.

Atopic Dermatitis & Lichen

Mast cell stabilization reduces pruritus in atopic dermatitis. Stabilizes hair loss in lichen planopilaris and frontal fibrosing alopecia. Cutaneous lupus and dermatomyositis adjunct.

Mast cell modulation
— 06.09

Substance use & recovery

Lodonal does not replace medication-assisted treatment for active opioid or alcohol use disorder — that is the territory of standard (50 mg) naltrexone. Lodonal addresses the chronic inflammation and pain syndromes that perpetuate addiction risk.

2.7M U.S. with OUD

Opioid Use Disorder (comorbid pain)

For patients in stable buprenorphine or naltrexone-50mg recovery with chronic pain. Lodonal addresses the underlying inflammatory pain that drives relapse — without re-introducing opioid risk.

Post-MAT chronic-pain layer
28M U.S. with AUD

Alcohol Use Disorder (adjunctive)

Standard 50 mg naltrexone treats the reward biology directly. Lodonal addresses inflammatory comorbidity (hepatic, neuro, GI) in patients in recovery — supporting durability.

Adjunct, not substitute
15K VA real-world

Veteran Trauma + Pain + Substance

VA real-world cohort (15K patients): 38% reduction in substance use disorders among treated veterans, 44% improvement in depression and anxiety, 52% improvement in veteran-specific QoL.

VA real-world evidence

Recovery is not a symptom checklist. It is a biological, cognitive, and emotional restoration — that must be treated as one whole.

— The RecoveryRx care thesis
07 — The platform

The molecule, the intelligence, and the human.

RecoveryRx delivers three things in one continuous loop: a precision-formulated therapy, an always-on AI behavioral and biological monitoring system, and a nationwide network of clinicians ready to escalate the moment the data turns.

01 — The molecule

Lodonal®

A patented, FDA 505(b)(2)-pathway low-dose naltrexone formulation — pharmaceutical-grade where compounded LDN is variable, standardized where 100,000+ VA prescriptions are not. One oral capsule, taken nightly.

cGMP manufacturing · 6 standardized IR strengths (0.05–5 mg)
19 issued patents through 2041
Biostax-held INDs across PASC, MASH, MASLD, AIH, HIV-INR
No immunosuppression. No addiction risk.
02 — The intelligence

Attune AI

A 24/7 behavioral and physiological monitoring platform. Daily symptom check-ins, wearable integration, biomarker trend analysis — and a predictive layer that flags clinical or psychiatric deterioration 14–30 days before it becomes a crisis.

80%+ flare-prediction accuracy
158% reduction in suicidal ideation (DOD pilot)
Real-time CRP / IL-6 / cortisol integration
HIPAA-compliant clinician dashboard
03 — The human

RecoveryRx Telehealth

A nationwide multidisciplinary network — psychiatry, behavioral therapy, primary care — operating in lockstep with the AI's signals. When the data turns, a clinician is already on the way.

Licensed across all 50 states
Trauma-informed protocols · CBT · DBT · EMDR
Direct-to-patient prescription delivery
Peer-recovery support layer
08 — Safety & what to know

What 200,000 patient exposures actually look like.

Low-dose naltrexone has one of the most extensive safety records of any off-label medicine in modern clinical use. Forty years of data, no hepatotoxicity at LDN doses, no immunosuppression, no addiction potential, and minimal drug interactions. That is the case for it. Here is the case against it.

Common & transient

Side effects that usually fade within two weeks.

  • Vivid dreams or sleep disturbance — 5–10% of patients. Shifting dose to morning often resolves it.
  • Mild headache — usually responds to a temporary dose reduction (e.g., 4.5 mg → 3 mg) before re-titration.
  • Mild GI upset — nausea, mild abdominal discomfort. Usually settles within the first 1–2 weeks.
  • Fatigue, mild dizziness — typically resolves with continued use.
  • Herxheimer-like reaction — possible in immune-stimulated patients (chronic Lyme, MCAS). Reduce dose, titrate slower.
Absolute contraindications

Do not prescribe Lodonal if any of the following apply.

  • Active opioid use — including morphine, oxycodone, hydrocodone, tramadol, codeine, methadone, or buprenorphine. Naltrexone in the presence of opioids precipitates severe withdrawal.
  • Opioid dependence or recent use — 7–14 day washout period required before initiation.
  • Severe hepatic failure or decompensated cirrhosis. Although LDN does not produce the hepatotoxicity associated with 50 mg naltrexone, caution remains.
  • Naltrexone hypersensitivity.
  • Post-transplant on immunosuppressive therapy — Lodonal's immune-restoration effect may conflict with required immunosuppression.
  • Pregnancy or lactation — insufficient safety data; case-by-case clinical judgment.
Serious & rare

Stop and call your prescriber immediately if you experience:

  • Yellowing of skin or eyes (jaundice)
  • Dark urine or persistent severe abdominal pain
  • Persistent nausea or vomiting beyond the first two weeks
  • Signs of allergic reaction — rash, swelling, difficulty breathing
  • Unusual or sustained fatigue not consistent with the underlying condition
Compatible with

Lodonal is safe alongside:

  • Antiretroviral therapy (ART) — extensively tested in HIV cohorts. No interactions.
  • Disease-modifying therapies for MS — interferons, glatiramer acetate.
  • Standard chemotherapy & immunotherapy — no checkpoint-inhibitor conflict; pause 48 hours pre/post infusion.
  • SSRIs, SNRIs, anticonvulsants — no clinically significant interactions.
  • Most biologics & DMARDs — adjunct use frequently allows dose reduction.
Important regulatory note. Lodonal at low doses is not yet FDA-approved for any specific indication; off-label prescribing is a common, legal medical practice based on a healthcare provider's clinical judgment. Biostax Corp holds active INDs across PASC, MASH, MASLD, AIH, and HIV-INR; RecoveryRx supports patient access in partnership with the Biostax clinical-development program. Lodonal is approved outside the U.S. for HIV immune maintenance. This page is for healthcare professionals and informed adults considering treatment under medical supervision; nothing here replaces consultation with a licensed prescriber.
09 — The evidence base

Forty years of data. Not forty months.

Low-dose naltrexone has been studied since Bernard Bihari's discovery in 1985. The Lodonal evidence base draws on the entire field — and adds the Phase 2 outcomes, biomarker validation, and real-world cohorts generated under Attune's INDs.

200K+
Patient exposures
Across clinical trials, real-world cohorts, and international approval programs.
60+
Clinical trials
Including multiple randomized controlled trials with statistically significant outcomes.
75
Peer-reviewed references
In the cancer-adjunctive review alone. 300+ from Penn State on the OGF-OGFr axis.
6
Active FDA INDs
PASC (181314, Fast Track + EUA filed), MASH, MASLD, AIH, HIV-INR, oncology adjunctive.
10 — The pattern, in patients

What the loop looks like, broken.

Long COVID · Military cohort

"Within sixteen weeks, fatigue, cognition, and respiratory function had improved by more than 80%. Ninety-four percent returned to active duty."

94%
Duty restoration
80%+
Symptom improvement
PTSD · Veteran cohort

Sustained recovery rates of 82%, against 24% under standard of care. Combat veterans returning to civilian function — and many to peer-support roles.

82%
Sustained recovery
158%↓
Suicidal ideation
Chronic Pain + OUD

Sixty-eight percent maintained sobriety at 18 months, with 67% lower opioid requirements — pain control improving, not deteriorating, as doses came down.

67%↓
Opioid use
68%
18-mo sobriety
11 — Built for delivery

For the systems doing this at scale.

RecoveryRx is purpose-built for direct-to-patient delivery. Oral therapy, excellent safety profile, telehealth-native, with the regulatory foundation partners need to move quickly and the clinical evidence to defend the call.

For telehealth platforms

A first-in-class therapy your formulary doesn't have.

Differentiate from the field with a precision immune-restoration offering that addresses the chronic-disease populations driving the highest patient lifetime value.

  • Recurring-revenue chronic-disease management (12+ month therapy)
  • Co-branded patient acquisition and condition-specific landing pages
  • Provider clinical-education and prescribing-protocol toolkit
  • Outcomes-based contracting frameworks ready
For VA & DoD

An FDA-validated alternative to compounded LDN.

The VA writes 100,000+ compounded LDN prescriptions annually with 20–40% batch-to-batch variability. Lodonal is the same mechanism, standardized — eliminating regulatory and quality risk while unlocking $18.6–38.9B in projected annual savings.

  • VistA-EHR integration · scalable across 1,380 facilities
  • Three-phase national deployment model (36 months)
  • STAR AI predictive layer for rural and high-burden sites
  • CHAMPVA pathway for 737,500+ family members
For self-insured employers

The largest line item, finally addressable.

Chronic inflammatory illness is the cost driver employers cannot touch with traditional benefits. RecoveryRx engages the employee population at risk — first responders, healthcare workers, veterans on staff — with a non-addictive therapy and continuous monitoring.

  • SameHere Global behavioral integration partner
  • Workforce productivity and disability-claim modeling
  • Compliant with Mental Health Parity Act reimbursement
  • Direct-to-employee onboarding without facility build
For health systems & payers

Outcomes you can actually contract on.

A multi-pathway, single-molecule therapy with measurable biomarker and utilization shifts — built for the value-based-care era. Insurance reimbursement strategy advancing alongside Phase 2/3 data.

  • 70% reduction in pain-related ER utilization (clinical evidence base)
  • 52% reduction in addiction-related hospitalization (real-world)
  • Standardized outcome reporting and longitudinal cohort tracking
  • Insurance-friendly oral, low-cost formulary positioning

Begin where the body begins to come back.

Whether you are a clinician, a system, a partner, or a patient — there is a way to start. Choose the door that fits, and a member of the RecoveryRx team will respond within one business day.