DSIP nasal spray, injected DSIP, and oral DSIP are not equivalent forms of administration. Available scientific evidence, absorption barriers, product requirements, and expected exposure differ significantly between these routes.
The best available human data on delta sleep-inducing peptide (DSIP), also known as emideltide, come from small historical studies in which the peptide was administered intravenously under investigator supervision. Subcutaneous administration of DSIP has been studied in animals, including in a cat sleep experiment, but it has not been validated as a treatment for insomnia in humans.
Nasal DSIP has also appeared in animal studies, including a stroke experiment in rats. However, there is no published clinical study in humans confirming the efficacy of the DSIP nasal spray in improving sleep.
Evidence regarding oral DSIP is even more limited. There are no reliable pharmacokinetic or clinical studies in humans showing that a standard DSIP tablet or capsule can survive the digestive process and achieve effective concentrations in the blood or brain.
Thus, the route of administration affects much more than just convenience. It can alter the amount of peptide absorbed in an intact form, the rate at which exposure is achieved, the tissues that come into contact with the formulation, and the manufacturing and sterility requirements. It also determines whether the results of one study can be reasonably applied to another product.
In this article, we compare individual routes of administration from a scientific perspective. We do not present injection sites, nasal spray preparation instructions, reconstitution methods, or dosages for injection or intranasal administration, because there is no approved protocol for the self-administration of DSIP.
In what forms is DSIP available or discussed?
DSIP is available or discussed online in several different forms. However, the mere availability of a particular product does not mean that it has been approved, has proven clinical efficacy, or is properly absorbed via a given route.
The most common forms include lyophilized peptide in vials, ready-to-use or compounding-declared nasal sprays, liquid research solutions, tablets, capsules, and multi-ingredient preparations.
Freeze-drying refers to sublimation drying, or drying by freezing. It defines the physical form of the peptide and may facilitate its storage or improve its stability prior to solution preparation. However, it does not confirm the identity of the peptide, its purity, sterility, endotoxin level, stability after reconstitution, or suitability for injection.
The exact form of the molecule is also important. Native DSIP is a nine-amino-acid peptide with the sequence Trp-Ala-Gly-Gly-Asp-Ala-Ser-Gly-Glu and a molecular weight of approximately 848.8 g/mol [1]. DSIP acetate contains an acetate counterion and has a different reported molecular weight.
Phosphorylated DSIP, truncated analogs, KND-related peptides, DSIP fusion constructs, and Deltaran are distinct research materials. Results pertaining to one of these forms cannot be automatically applied to a product labeled simply as „DSIP peptide spray” or „DSIP injection.”.
Product descriptions can also lead to misunderstandings. The term „research use only” usually means that the product is not offered as an approved drug intended for use in humans. The term „compounded” should refer to the preparation of a product within a legal, regulated pharmacy compounding system, if permitted in the given jurisdiction. It should not be a general term for any ready-made preparation sold on the internet.
A professional-looking vial, spray bottle, or label does not in and of itself confirm compliance with the standards required for medicinal products.
There is no DSIP product approved by the FDA or the EMA for the treatment of insomnia or the improvement of sleep. The FDA’s Substance Registry identifies emideltide as a specific chemical substance, but explicitly states that the assignment of a substance identifier does not imply regulatory evaluation or approval [2].
For this reason, commercial forms of DSIP must be clearly distinguished from the forms and routes of administration that have actually been scientifically studied.
DSIP nasal spray and intranasal administration
Intranasal administration of DSIP is a scientifically feasible experimental route of administration, but no clinical trial in humans has confirmed that a DSIP nasal spray is an effective or reliably absorbed treatment for sleep disorders.
The nasal cavity contains a large surface area of well-vascularized respiratory mucosa and a smaller olfactory area, which has anatomical connections to the central nervous system. Nasal administration bypasses the gastrointestinal tract and may allow certain substances to cross into the blood through the nasal mucosa. For selected molecules, a certain portion of the substance may also reach brain-related structures via the olfactory region or the trigeminal nerve.
However, this does not mean that every peptide automatically travels from the nose to the brain.
Intranasal absorption is influenced by many factors. These include the deposition site of the aerosol, device design, droplet size, fluid volume, peptide solubility, pH, osmolality, preservatives, penetration enhancers, presence of mucus, local enzymes, and mucociliary clearance.
A review on intranasal peptide delivery found that the bioavailability of peptides administered via this route is often low and highly dependent on the formulation. The authors reported that for many available intranasal peptide products, bioavailability in humans is below 5%, although this value varies depending on the molecule and formulation. Efficacy can be significantly influenced by factors such as pH, osmolality, solubility, site of deposition, absorption-enhancing agents, and mucoadhesive properties [3].
Therefore, the amount of DSIP stated on the aerosol label cannot be equated with the amount that actually reaches the blood or the brain.
The most significant published experiment on intranasal DSIP discussed in this context was conducted on animals, not humans. In a 2021 study, rats were administered 120 µg/kg of DSIP intranasally approximately one hour before experimentally induced focal cerebral ischemia, and then for seven days following reperfusion. The treated animals showed faster improvement in motor function; however, the difference in infarct volume was not statistically significant [4].
The study examined post-stroke recovery in rats and used a specific experimental formulation and protocol. It did not evaluate insomnia, sleep onset, intranasal absorption in humans, safety in humans, or the commercial DSIP aerosol.
This is particularly important for searches such as „DSIP nasal spray for sleep dosage instructions.” The dose administered intranasally in a stroke study in rats cannot be converted into a dosing regimen for the nasal spray before bedtime in humans.
Rats and humans differ in nasal anatomy, mucosal surface area, breathing patterns, metabolism, drug delivery, and scaling relative to body weight. Improved motor function following an experimental stroke also does not indicate a beneficial effect on sleep.
Internet reviews referred to as „DSIP nasal spray review” should also be approached with caution if they do not refer to a controlled clinical trial in humans. Individual experiences may depend on expectations, the concomitant use of melatonin or sedatives, changes in sleep habits, differences between products, and the natural night-to-night variability of sleep.
Such data do not allow for the determination of bioavailability or confirmation that the product actually contains the declared amount of DSIP.
DSIP by injection and subcutaneous administration
Injectable DSIP has the best-documented research history; however, data from human studies primarily involve intravenous administration. These data do not support current practices involving self-administered subcutaneous injections.
Intravenous administration delivers a substance directly into the bloodstream. This is precisely the route that was used in historical studies of sleep in humans.
In a single controlled crossover study, six healthy adults received a slow intravenous infusion of 25 nmol/kg. The researchers reported an immediate increase in sleep pressure and subsequent changes in nocturnal sleep parameters [5].
In another early study, the same body-weight-based dose was administered intravenously to six individuals with chronic insomnia [6]. In subsequent controlled studies of insomnia, 25 nmol/kg administered intravenously was also used. The results included both minor objective changes and effects of limited clinical significance, as well as a lack of marked improvement in subjective sleep quality [7,8].
These studies cannot be treated as evidence of the efficacy of subcutaneous DSIP.
When administered subcutaneously, the substance enters the tissue beneath the skin. It must then travel through the tissues before reaching the local blood vessels or the lymphatic system. Absorption may therefore be slower or incomplete and depends, among other factors, on the formulation, the volume administered, tissue blood supply, local enzymes, and the stability of the peptide.
Using the same number of micrograms as in an intravenous study does not guarantee that the same concentration or time-course exposure profile will be achieved.
The most direct data on subcutaneous DSIP and sleep come from animal studies. In one experiment, eight cats were administered 120 nmol/kg of DSIP subcutaneously prior to an eight-hour sleep recording. An increase in deep slow-wave sleep and delta activity on the EEG was observed. However, changes in total wakefulness time, total slow-wave sleep, time to fall asleep, and REM latency were not statistically significant, and total REM sleep time remained unchanged [9].
The study shows that subcutaneous DSIP can produce measurable biological effects in cats under specific experimental conditions. However, it does not specify the dose for humans, the frequency of administration, the safety margin, or its efficacy in treating insomnia.
Another example is Deltaran, a preparation containing DSIP. Female SHR mice were administered approximately 100 µg/kg subcutaneously for five consecutive days each month, starting at three months of age until natural death [10]. The study focused on lifespan and cancer-related processes, not sleep in humans. It also used a specific preparation containing DSIP. Therefore, this protocol cannot serve as the basis for an online „DSIP injection cycle” for humans.
Injections also entail additional requirements regarding product quality. A parenteral preparation must be properly manufactured and tested for sterility, endotoxins, particulate matter, identity, concentration, and stability.
Chemical purity is not the same as sterility. For example, a high purity result obtained using the HPLC method does not rule out the presence of microorganisms, endotoxins, abnormal concentrations, or unsuitable excipients.
This applies to intravenous, subcutaneous, intramuscular, and other parenteral routes of administration.
Oral DSIP: tablets, capsules and pills
There is no credible evidence showing that standard tablets, capsules, or other oral forms of DSIP deliver a clinically effective amount of the intact peptide in humans.
Peptides taken orally face two main obstacles.
First, in the stomach and intestines, they are exposed to acid, fluctuating chemical conditions, and digestive enzymes that can break down peptide bonds.
Secondly, even if a portion of the intact peptide reaches the small intestine, its penetration through the intestinal wall may be minimal. Peptides are typically larger, more polar, and less able to penetrate cell membranes than conventional small-molecule drugs.
In a peer-reviewed review on the oral delivery of peptides, enzymatic degradation and poor intestinal permeability were identified as some of the main reasons why most peptide drugs cannot simply be administered in a standard tablet or capsule [11].
Evidence suggesting that DSIP can cross the blood-brain barrier model does not mean it works when ingested. The digestive tract and the blood-brain barrier are completely different biological barriers.
For orally administered DSIP to reach the brain, it would first need to remain sufficiently intact during digestion. It would then need to cross the intestinal barrier, enter the systemic circulation, avoid excessive degradation, achieve adequate exposure, and ultimately reach the cerebral circulation.
Data concerning the final stage, i.e., the blood-brain barrier, cannot replace evidence concerning all preceding stages.
Some peptide drugs have been successfully developed in oral form. However, these products typically require molecule-specific formulation technology, absorption enhancers, protective systems, or special pharmacological properties. Their existence does not prove that a standard DSIP capsule works in the same way.
None of the discussed DSIP studies determine the oral bioavailability, pharmacokinetics, sleep improvement efficacy, or safety of conventional tablets, capsules, pills, sublingual lozenges, or buccal preparations.
The oral product may also contain substances other than intact DSIP or rely solely on an unverified manufacturer's declaration. Without analytical and clinical studies, the apparent effect may result from another ingredient, user expectations, or natural sleep variability.
Therefore, the term „oral DSIP supplement” should not be treated as proof that native emideltide reaches the bloodstream or the brain.
DSIP nasal spray vs injection
Injection can provide more predictable systemic exposure in controlled research settings, whereas intranasal administration is non-invasive, but heavily dependent on the formulation and device performance. Neither of these routes has been approved as a treatment for insomnia using DSIP.
The difference is more complex than simply stating that the injection is „stronger” and the nasal spray is „easier.”.
Intravenous administration bypasses the absorption process and was used in small historical human sleep studies [5–8]. Subcutaneous administration still requires absorption from tissues and there are no comparable controlled data regarding human insomnia.
Intranasal administration avoids needles and degradation in the digestive tract, but no human pharmacokinetic study of DSIP has been conducted to determine how much is absorbed, what fraction reaches the brain, how repeatable the dose delivered by each spray is, and how exposure relates to sleep effects.
| Path or form | Published data regarding DSIP | The main problem related to delivery | What has not been determined yet |
|---|---|---|---|
| Intravenous administration | Small human sleep and insomnia studies, typically 25 nmol/kg under supervision [5–8] | Direct systemic exposure, but it requires clinical administration and parenteral material of appropriate quality | Approved dose for insomnia, long-term safety, and broad clinical efficacy |
| Subcutaneous administration | Sleep study in cats and other animal experiments [9,10] | Absorption from tissues; exposure and stability may differ from intravenous administration | Human bioavailability, sleep efficacy, dosing schedule, and route equivalence |
| Nasal spray | Study on post-stroke recovery in rats with 120 µg/kg; lack of validated sleep study in humans [4] | Variable deposition, mucociliary clearance, enzymes, small administration volume and formulation dependence | Human nasal bioavailability, sleep doses, onset of action, safety, and advantages over injection |
| Standard tablet or capsule | Lack of reliable clinical bioavailability or sleep efficacy studies | Gastrointestinal degradation and poor intestinal permeability [11] | Is there significant exposure to an intact DSIP? |
| Direct administration into the brain or brain ventricles | Historical animal experiments | It limits peripheral absorption, but it is highly invasive and research-specific. | Meanings for consumer nasal, oral, and subcutaneous products |
No direct human studies have been conducted comparing intranasal DSIP aerosol to intravenous or subcutaneous administration. Therefore, claims that intranasal DSIP acts faster, injections are stronger, or one route requires a specific multiple of the other's dose remain unverified.
Subjective feelings regarding the speed of action do not allow for the determination of bioavailability.
How does the route of administration affect absorption and the interpretation of test results?
The route of administration alters pharmacokinetic issues. Results obtained for one route cannot simply be transferred to another without appropriate comparative studies.
In the case of intravenous administration, systemic bioavailability is generally considered to be 100 percent, since the substance enters the bloodstream directly.
Subcutaneous bioavailability should be measured relative to intravenous exposure, typically by comparing concentration-time curves.
Nasal bioavailability also requires validated analytical methods capable of distinguishing intact DSIP from its metabolites or chemically similar substances.
In the case of oral administration, evidence would be needed that the intact peptide actually reaches the systemic circulation after passing through the digestive tract.
DSIP has also been studied in the context of the blood–brain barrier, but these results require cautious interpretation.
In 1982, anesthetized dogs were administered an intravenous bolus of DSIP or selected analogs at a dose of 100 µg/kg. Subsequently, the researchers detected increased DSIP-like immunoreactivity in the cerebrospinal fluid [12].
Rat studies have also shown differences in brain penetration among DSIP-related peptides [13]. In an in vitro model using brain microvascular endothelial cells, bidirectional, non-saturable transport of DSIP was observed, consistent with limited simple diffusion. Apparent permeability was similar to water-soluble markers with limited penetration capacity [14].
The results suggest that under specific experimental conditions, a certain amount of DSIP or DSIP-related material can move from the blood toward the central nervous system. However, they do not indicate how much intact DSIP reaches the human brain after intranasal, subcutaneous, or oral administration.
The experiment on dogs used an intravenous bolus, whereas the cellular model did not reproduce the full physiology of a living human. Older immunoassays may also have detected DSIP-related molecules or its metabolites, rather than exclusively the intact peptide.
The formulation can affect exposure even when the route of administration is the same. For intranasal products, factors such as pH, tonicity, viscosity, preservatives, concentration, spray characteristics, droplet distribution, and device performance may be important [3].
In injection preparations, excipients and peptide aggregation can affect stability and tissue reactions. Tablet coatings, enzyme inhibitors, and absorption enhancers, on the other hand, can significantly alter oral peptide delivery [11].
Therefore, the mere information that a product is „nasal”, „injectable”, or „oral” is not sufficient. Studies should also include the specific formulation and delivery system.
DSIP injection sites: why search interest outweighs the evidence?
Information about where to administer DSIP injections is frequently searched for, but this interest stems mainly from online discussions about self-administration rather than clinical trials determining safe administration sites.
In peer-reviewed human sleep studies, DSIP was administered intravenously under research or clinical supervision [5–8]. The abdomen, thigh, arm, or other potential sites for subcutaneous administration have not been compared.
Animal studies used routes and sites of administration appropriate for the given species and specific experimental protocol. These methods cannot be translated into human dosing instructions.
No controlled study has shown that a specific subcutaneous injection site provides better absorption of DSIP, a stronger effect on sleep, or greater safety in humans.
Specifying a precise injection site would also require assuming that the peptide itself, its concentration, sterility, equipment, and intended method of use are appropriate. Such assumptions cannot be made in the case of an unapproved research peptide.
Improper parenteral administration can lead to infection, abscesses, tissue damage, dosage errors, vascular or nerve damage, allergic reactions, and exposure to contaminated or improperly labeled material.
Therefore, there is no evidence-based body site or procedure that can be presented as an established method for self-administering DSIP injections. Currently, there is no regulatory-approved protocol for self-injections of DSIP or a preferred site for administering them.
DSIP Dosages in Nasal Sprays and Restrictions on Such Information
Claims regarding the dosage of DSIP in nasal spray are not supported by validated human sleep studies. The given number of micrograms per spray also does not indicate how much DSIP will be absorbed or reach the brain.
The label on a nasal spray product may specify the amount per spray, the total amount in the bottle, the concentration of the solution, or simply the amount corresponding to the contents of the original vial. These values are not equivalent.
Even if the pump delivers a constant volume of fluid, the actual mass of the substance depends on its concentration and the operation of the device. The amount absorbed then depends on where the fluid is deposited, its outflow or ingestion, mucociliary clearance, the condition of the nasal mucosa, enzymatic degradation, and the properties of the formulation.
The amount that ultimately reaches the brain is a separate issue.
The intranasal dose of 120 µg/kg used in the 2021 rat study should not be presented as a human sleep dose without considering the context [4]. This was a stroke experiment in which the peptide was administered before vessel occlusion and then for seven days following reperfusion. Neither insomnia nor a commercial nasal spray was studied.
Simply converting the dose used in rats based on human body weight would not be a valid clinical method.
Internet sources may recommend a specific number of sprays, a specific time before sleep, or a cycle length. If such recommendations are not supported by a peer-reviewed human study utilizing the same molecule form, formulation, concentration, device, and intended use, they should be treated as vendor instructions or anecdotal practices rather than independent clinical evidence.
There is also a lack of sufficient published data to determine the shelf life, refrigerated storage time, preservation system, or the maintenance of activity in commercial DSIP aerosols after opening.
Preparing the DSIP aerosol on one’s own introduces further uncertainties. Proper formulation of a nasal pharmaceutical product requires monitoring of concentration, pH, osmolality, microbiological quality, the efficacy of the preservative system (if used), packaging compatibility, pump accuracy, the reproducibility of the delivered dose, peptide stability, and nasal mucosal tolerance.
Simply dissolving the lyophilized peptide in liquid and placing it in a spray bottle does not confirm any of these parameters.
For this reason, there is no evidence-based home recipe for preparing DSIP nasal spray.
"Research-only" products vs. approved drugs
The DSIP product, intended solely for research purposes, is not an approved drug, regardless of whether it is sold as a nasal spray, an injection vial, a tablet, or a capsule.
Approved drugs are evaluated for manufacturing process consistency, identity, strength, purity, stability, clinical efficacy, safety, labeling, and post-market safety monitoring for specific routes of administration and indications.
The route of administration is part of the approval process. Data supporting an injectable drug do not automatically imply approval of its intranasal or oral formulations. For intranasal products, device performance and the reproducibility of the delivered dose are also important quality factors.
Research chemicals may have legitimate laboratory applications, but the term „research grade” is not a regulatory clinical category confirming that the material is suitable for human administration.
A certificate attesting to the high purity of a peptide does not replace the sterility and endotoxin tests required for injectable products, preservative tests and dose reproducibility tests for nasal sprays, or dissolution and bioavailability tests for oral products.
Geographic search terms, such as „DSIP nasal spray UK,” do not alter the quality of the scientific evidence. The fact that a product is advertised or shipped within the United Kingdom does not mean that it has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
Regulatory status and formulation guidelines are subject to change. Official drug databases and qualified healthcare professionals are therefore more reliable sources of information than commercial product descriptions [15].
FAQ: Ways to Submit a DSIP
Does the DSIP nasal spray have a confirmed effect on sleep?
No. There are no published clinical studies in humans that confirm the effectiveness of DSIP nasal spray in treating insomnia or improving sleep quality. The study on intranasal DSIP in question was conducted on rats following an experimental stroke and was not a sleep study in humans [4].
Is DSIP in injection form better than a nasal spray?
No direct human study has answered this question. Intravenous DSIP has been studied in small human sleep trials, whereas comparable data regarding insomnia are lacking for the intranasal and subcutaneous routes. More predictable systemic exposure following intravenous administration does not automatically mean a better clinical effect.
Has subcutaneous DSIP been studied in relation to sleep in humans?
Major studies on sleep in humans have used intravenous administration. In a subcutaneous experiment in cats, an increase in deep slow-wave sleep and delta activity on the EEG was observed, but several other sleep parameters did not change significantly [9]. The results from animal studies do not allow for the establishment of a subcutaneous protocol for humans.
Can DSIP be taken by mouth?
There are no reliable human data showing that a standard DSIP tablet or capsule delivers an effective amount of intact peptide. Research on peptide delivery shows that gastrointestinal enzymes and poor intestinal permeability pose significant barriers to their oral absorption [11]. A specially developed oral DSIP formulation would require its own pharmacokinetic and clinical studies.
Does DSIP cross the blood–brain barrier?
Animal studies and in vitro models suggest that a certain amount of DSIP or DSIP-related material may cross the blood-brain or blood-cerebrospinal fluid barriers following systemic exposure [12–14]. However, this does not prove the effective delivery of DSIP to the human brain following nasal spray, subcutaneous, or oral administration.
What is the dosage of DSIP nasal spray for sleep?
No validated intranasal DSIP dose for sleep has been established in humans. Dosages derived from rat studies, vendor websites, or user reports should not be presented as clinical guidelines. The aerosol concentration, device performance, absorption rate, stability, and brain exposure for an approved DSIP product for sleep have not been determined.
How much DSIP should be injected?
There is no approved DSIP dose for self-injection. Historical human studies used supervised, body-weight-based intravenous protocols, rather than modern commercial subcutaneous products. Converting these experimental amounts to a dose for home injection would overlook differences in bioavailability, formulation, purity, sterility, and individual risk.
Where should DSIP be injected?
Published evidence does not specify a safe or preferred site for self-injection of DSIP. Human sleep studies have used supervised intravenous administration and have not compared subcutaneous injection sites. Therefore, no evidence-based site exists for the self-injection of DSIP.
Can a nasal spray be prepared from freeze-dried DSIP?
Simply dissolving the material and placing it in a spray bottle does not create a validated nasal medication. Pharmaceutical nasal products require confirmation of concentration, stability, pH, osmolalinity, microbiological quality, packaging compatibility, pump accuracy, delivered dose uniformity, and mucosal tolerance. An evidence-based home method for preparing such a product cannot be recommended.
Are oral DSIP capsules safer than injections?
There is insufficient data to draw such a conclusion. Oral administration eliminates the risks directly associated with needles, but the product’s identity, ingredients, stability in the gastrointestinal tract, absorption, interactions, and clinical safety remain uncertain. Poor absorption may result in a lack of efficacy, while incorrect ingredients or contaminants may pose other risks.
Is the DSIP nasal spray approved in the UK?
Based on the discussed data, DSIP/emideltide is not a UK-approved medicine for insomnia. The mere fact that the product is advertised or shipped within the UK does not confirm MHRA authorization. Since the regulatory status may change, current information should be checked in official sources [15].
Limitations of the Available Data
A direct comparison of different routes of administration of DSIP is difficult because the peptide has not undergone a modern formulation development program.
Human sleep studies have primarily used intravenous administration and involved very small groups of participants. The most important data regarding subcutaneous administration in the context of sleep come from an animal experiment, while the available intranasal study concerned stroke recovery in rats, not human sleep. No clinically relevant data regarding standard oral DSIP have been established either.
Studies on the blood-brain barrier do not resolve these limitations. They suggest that under specific conditions of systemic exposure, penetration into the central nervous system may occur, but they do not provide reliable human bioavailability values for individual routes of administration.
Older immunoassay tests may also detect DSIP-like material rather than exclusively intact peptide. Results obtained in dogs, rats, cats, or laboratory cell models cannot be directly used to predict intact DSIP concentrations in the human brain.
Differences between products represent another significant limitation. Native DSIP, DSIP acetate, phosphorylated analogues, fusion peptides, and combination preparations should not be treated as the same substance.
Commercial products may also differ in excipients, concentration, delivery devices, storage conditions, and quality control. Without independent analytical and clinical data for a specific product, comparisons between routes of administration remain largely experimental or theoretical.
Disclaimer
This article is for educational and scientific-informational purposes only. It does not constitute medical advice, dosage instructions, injection instructions, a recipe for preparing a nasal spray, or purchasing advice.
The content should not be used for self-administering or preparing an unapproved peptide. Delta sleep-inducing peptide (DSIP/emideltide) is not approved by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), or the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of insomnia, sleep improvement, stroke recovery, or any other uses discussed in this article.
Human data are limited and come mainly from controlled intravenous administration studies. Evidence regarding subcutaneous, intranasal, and oral administration is preclinical, absent, or remains insufficient.
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