pe
pep-10914 v1 CC-BY-SA-4.0

Orexin-A: the brain's 'stay awake' signal (Hypocretin-1)

A natural brain peptide that keeps you awake and alert; its loss causes narcolepsy type 1, a condition of sudden uncontrollable sleepiness. Used as a research tool.

statuscomputed targetOX2R length33 aa refs1
status 2 / 5
prediction metrics openfold3-mlx 0.3.1
ipTM0.595
pTM0.791
avg pLDDT60.3
ranking score0.700
STRUCTURE · PEP-10914 × OX2R
ranking0.700
target interface 4.5Å peptide drag rotate · ctrl+scroll zoom · right-click pan
openfold3-mlx 0.3.1 · mmCIF ↓ download
sequence33 aa
15101520253033
RPLPDCCRQKT CSCRLYELLHG AGNHAAGILTM
in the news 1 article
overview readme

What this is

Orexin-A (also called hypocretin-1) is a 33-amino-acid brain peptide made by a small cluster of neurons in the lateral hypothalamus. It is the body's main "stay awake" signal: when these neurons are destroyed by an autoimmune process, the result is narcolepsy type 1, the disorder defined by sudden uncontrollable sleepiness and cataplexy. The peptide carries two intramolecular disulfide bonds that hold it in the shape required to engage its two receptors (OX1R and OX2R); those bonds are essential for activity and are not represented in the raw 33-letter sequence shown on this card.

Interest in orexin-A as a drug has centered on replacing the lost signal in narcolepsy type 1. Because the peptide does not cross the blood-brain barrier well, the small human studies that have been done used intranasal delivery, which reaches the brain via the olfactory and trigeminal pathways. The broader clinical field has now shifted toward oral small-molecule OX2R-selective agonists, which have shown strong Phase 2 results in narcolepsy type 1 (Dauvilliers et al., NEJM 2025).

History

Orexin-A was discovered twice in the same few weeks of early 1998 by two independent groups working on different questions. At The Scripps Research Institute, de Lecea, Sutcliffe and colleagues used a subtractive-hybridization screen for hypothalamus-specific transcripts and named the resulting peptides "hypocretins" — for their hypothalamic origin and their distant structural relationship to the gut hormone secretin (de Lecea et al., PNAS 1998). At UT Southwestern, Sakurai, Yanagisawa and colleagues identified the same molecules as the natural ligands of two orphan G-protein-coupled receptors and named them "orexins" — from the Greek for appetite — after observing that intracerebroventricular injection stimulated feeding in rats (Sakurai et al., Cell 1998). Both names are still in routine use today.

The link to narcolepsy was made two years later. Nishino, Mignot and colleagues showed that cerebrospinal-fluid hypocretin-1 (orexin-A) was undetectable in most narcolepsy patients (Nishino et al., Lancet 2000), and Peyron and colleagues documented a generalized loss of hypocretin peptides — and a rare causative gene mutation — in postmortem narcoleptic brains (Peyron et al., Nature Medicine 2000). Together those papers redefined narcolepsy type 1 as an orexin-deficiency disorder and turned the orexin system into a major target for both sleep-promoting and wake-promoting drugs.

What it does

Orexin-A behaves as the brain's general arousal signal. It activates several upstream wakefulness systems at once — the noradrenergic locus coeruleus, the histaminergic tuberomammillary nucleus, the serotonergic raphe nuclei, and the dopaminergic ventral tegmental area — and also touches the hypothalamic-pituitary-adrenal axis, sympathetic outflow, and energy metabolism (Sakurai et al., Cell 1998; de Lecea et al., PNAS 1998). When the orexin neurons are destroyed, these arousal systems lose their main coordinating input; the clinical result is the excessive daytime sleepiness, fragmented night sleep, and cataplexy that define narcolepsy type 1 (Nishino et al., Lancet 2000; Peyron et al., Nature Medicine 2000).

Evidence

  • Human: Small acute intranasal studies in narcolepsy type 1 patients have reported biologically interesting effects — improved sleep architecture and reduced direct wake-to-REM transitions (Baier et al., Sleep Medicine 2011), improved sleepiness and attention measures (Weinhold et al., Behavioural Brain Research 2014), and partial restoration of olfactory function (Baier et al., Brain 2008). A separate pilot in healthy males showed that intranasal orexin-A acutely raised resting muscle sympathetic nerve activity without changing blood pressure or heart rate (Schwarz et al., Journal of Neurophysiology 2022). No long-term controlled trial of intranasal orexin-A as a replacement therapy has been completed. Clinical translation of orexin agonism has shifted to oral OX2R-selective small molecules, where oveporexton (TAK-861) significantly improved wakefulness, sleepiness and cataplexy measures over 8 weeks in Phase 2 in narcolepsy type 1 (Dauvilliers et al., NEJM 2025).
  • Animal: Foundational rodent work characterized orexin-A's role in arousal, feeding, and sleep-wake control (Sakurai et al., Cell 1998).
  • In vitro: Orexin-A binds and activates both OX1R and OX2R as G-protein-coupled receptors; this was established at the receptor-binding and signaling level in the original discovery paper (Sakurai et al., Cell 1998).

Mechanism

Orexin-A is a dual agonist at OX1R and OX2R, two closely related GPCRs whose expression is concentrated in arousal-regulating brainstem and hypothalamic nuclei (Sakurai et al., Cell 1998). OX2R is particularly important for sleep-wake control, which is why OX2R-selective small-molecule agonists are now the dominant clinical-development direction (Dauvilliers et al., NEJM 2025). The two intramolecular disulfide bonds in orexin-A are not visible in the raw 33-letter sequence but are required for the peptide to adopt the conformation that activates its receptors; orexin-B lacks this disulfide architecture and has a much shorter biological half-life and a different receptor-selectivity profile (Sakurai et al., Cell 1998).

Narcolepsy type 1 reflects a near-total loss of the lateral-hypothalamic orexin neurons, with the corresponding collapse of cerebrospinal-fluid orexin-A to essentially undetectable levels (Nishino et al., Lancet 2000; Peyron et al., Nature Medicine 2000). That is the pathophysiological basis for orexin-replacement strategies. Systemic (subcutaneous, intravenous) administration is not expected to reproduce the central wakefulness effects because the peptide does not cross the blood-brain barrier well; intranasal delivery exploits olfactory and trigeminal pathways to reach the central nervous system, which is why the small human studies all used the intranasal route (Baier et al., Brain 2008; Baier et al., Sleep Medicine 2011; Weinhold et al., Behavioural Brain Research 2014).

Known effects

  • Acute wakefulness, attention, and sleep-architecture effects in narcolepsy type 1 — small controlled intranasal studies (Baier et al., Sleep Medicine 2011; Weinhold et al., Behavioural Brain Research 2014).
  • Acute restoration of olfactory function in narcolepsy type 1 — single controlled intranasal study (Baier et al., Brain 2008).
  • Acute sympathetic vascular activation in healthy adults — pilot study; increase in resting muscle sympathetic nerve activity without change in blood pressure or heart rate (Schwarz et al., Journal of Neurophysiology 2022).
  • Wakefulness promotion in healthy adults — not established; no rigorous clinical evidence supports cognitive or wakefulness benefit in non-deficient individuals.

Safety signals

Human safety data for exogenous orexin-A is limited to small acute studies; there is no long-term controlled exposure data. The most consistent acute signal is sympathetic activation: intranasal orexin-A in healthy males significantly raised resting muscle sympathetic nerve activity in a pilot study, although blood pressure and heart rate were unchanged at that dose and time point (Schwarz et al., Journal of Neurophysiology 2022). Mechanistically, orexin signaling drives sympathetic outflow and cardiovascular arousal, so chronic-exposure cardiovascular safety remains an open question (Sakurai et al., Cell 1998).

Combining orexin-A with a dual orexin receptor antagonist (suvorexant, lemborexant, or daridorexant) would be pharmacologically self-defeating — those drugs are designed to block exactly the receptors orexin-A activates. No reproductive, pediatric, or pregnancy data exist for exogenous orexin-A.

Regulatory status

  • US (FDA): Not approved for any indication. Not a controlled substance. Sold by research-chemical suppliers; not authorized for human therapeutic use.
  • EU (EMA), UK (MHRA), Australia (TGA), Japan (PMDA), Canada (Health Canada): Not approved.
  • WADA: Not explicitly named on the Prohibited List. Because orexin-A is not approved for human therapeutic use anywhere, the S0 "non-approved substances" clause is plausibly applicable; athletes should treat it as prohibited absent specific guidance.
  • Context: Dual orexin receptor antagonists (suvorexant, lemborexant, daridorexant) — which act in the pharmacologically opposite direction — are FDA-approved for insomnia. Oral OX2R-selective small-molecule agonists, most prominently oveporexton (TAK-861), have shown positive Phase 2 results in narcolepsy type 1 (Dauvilliers et al., NEJM 2025) but had not received regulatory approval as of writing.

Related peptides

  • Orexin-B (hypocretin-2) — the sister peptide from the same prepro-orexin precursor; shorter, lacks the disulfide architecture of orexin-A, and is more selective for OX2R (Sakurai et al., Cell 1998).
  • Suvorexant, lemborexant, daridorexant — small-molecule dual orexin receptor antagonists, approved for insomnia, that act in the pharmacologically opposite direction to orexin-A.
  • Oveporexton (TAK-861) — oral OX2R-selective small-molecule agonist in clinical development for narcolepsy type 1 (Dauvilliers et al., NEJM 2025); the leading non-peptide approach to restoring orexin signaling.

Open questions

  • Long-term intranasal orexin-A as replacement therapy in narcolepsy type 1. Only acute single-dose human studies have been reported; no controlled chronic trial has been completed.
  • Head-to-head positioning against oral OX2R agonists. As oveporexton and other oral OX2R-selective agents advance through late-stage trials, it is unclear whether intranasal peptide replacement retains a clinical niche.
  • Cardiovascular safety with chronic exposure. Acute sympathetic activation has been documented (Schwarz et al., Journal of Neurophysiology 2022); chronic-dose data do not exist.
  • Effects in narcolepsy type 2, idiopathic hypersomnia, and healthy adults. Available human data are dominated by narcolepsy type 1, where the orexin system is depleted; whether augmenting an intact orexin system is beneficial or harmful is not established.
  • Reproductive, pediatric, and pregnancy data. No human data in any of these populations.
Hypotheses5 directions▾ collapse

Research directions for this peptide, selected from the current sources — hypotheses you can explore and model. None of it is proven yet; tap any one to see the full thinking.

openupdated 2026-06-05

Is the selective preference of orexin-A for one receptor over the other controlled by the compact, knotted part of the molecule rather than its long spiral tail?

Knowing which part of orexin-A drives receptor selectivity would let researchers build versions that activate only the sleep-promoting receptor without activating the anxiety or addiction-related receptor, making safer treatments for narcolepsy and potentially for other conditions like depression and addiction.

The hypothesis
Orexin-A's differential potency at OX1R versus OX2R (with higher OX1R potency) is determined primarily by contacts from the disulfide-constrained N-terminal cystine-knot with receptor-specific residues in extracellular loop 2 of each receptor, and that the C-terminal helical segment (LYELLHGAGNHAAGILTM) contributes affinity but not selectivity for either subtype.
Why it’s plausible
OX1R and OX2R share approximately 64% sequence identity but differ substantially in their extracellular loops. Orexin-A binds OX1R with roughly 10-fold higher potency than OX2R. Published structures (10.1038/s41467-021-21087-6) show that orexin peptide N-terminal regions make receptor-specific contacts in the transmembrane bundle entrance and ECL2. If the C-terminal helix provides pan-receptor affinity through conserved TMD residues while the disulfide-knotted N-terminus provides subtype discrimination through variable ECL residues, truncation or substitution of N-terminal residues should selectively eliminate OX1R preference while preserving OX2R binding.
Why it matters
Demonstrating that the N-terminal cystine-knot mediates selectivity would guide design of OX1R-selective or OX2R-selective analogs for differential applications: OX2R-selective for narcolepsy (avoiding anxiety/panic from OX1R activation) versus OX1R-selective for addiction and reward research.
Plausibility.70
Novelty.40
Impact.65
Basis · grounding1 paper · 2 computed/notes
[1]
paper
Active-state OX2R structure rationalizing peptide recognition; extracellular loop and N-terminal orexin peptide contacts defined; comparison with OX1R structures reveals ECL differences
doi: 10.1038/s41467-021-21087-6
[2]
sequenceRPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM: N-terminal RPLPD before the first Cys are charged/proline-rich and likely make receptor-selective contacts; LYELLHGAGNHAAGILTM is a classic amphipathic helix likely engaging conserved hydrophobic TMD residues
[3]
noteTwo intramolecular disulfide bonds are essential for activity; OX1R and OX2R are both engaged; clinical field moved to OX2R-selective small molecules for narcolepsy, implying OX2R specificity is the therapeutic goal
openupdated 2026-06-05

Does a flexible bend in the middle of orexin-A control how tightly and how long it grabs its receptor?

Drugs that stay attached to their receptor longer often need to be taken less frequently and work better at lower doses. If scientists can stiffen or tune this hinge region, they could engineer intranasal orexin-A replacements that remain effective for hours rather than minutes, making treatment of narcolepsy much more practical.

The hypothesis
The GGAGNH motif within orexin-A's C-terminal segment (positions 24-29 in RPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM) functions as a helix-breaking glycine-rich region that creates a flexible hinge between the receptor-contact helix (LYELLH) and the C-terminal membrane-insertion tail (AGILTM), and replacement of both Gly residues with Ala would rigidify the C-terminus and alter the kinetics of receptor dissociation without affecting initial binding affinity.
Why it’s plausible
The C-terminal LYELLHGAGNHAAGILTM region of orexin-A is known to form an alpha-helix, but the sequence contains GAGNHA (positions ~24-29), which is rich in Gly and Asn, both helix-disrupting residues. This region likely forms a flexible loop or partial turn between two helical segments. The terminal AGILTM is markedly hydrophobic and may partially insert into the membrane or the hydrophobic transmembrane cavity of OX2R. A flexible hinge at GAGN would allow the terminal hydrophobic segment to pivot and engage the receptor or membrane independently of the main helix orientation, affecting dwell time and receptor activation kinetics.
Why it matters
Identifying a hinge-driven kinetics mechanism would enable engineering of orexin-A analogs with extended receptor residence time (slow off-rate agonism), a property associated with prolonged in vivo efficacy and reduced dosing frequency in intranasal or sustained-release formulations.
Plausibility.55
Novelty.55
Impact.55
Basis · grounding2 papers · 1 computed/note
[1]
sequenceRPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM: LYELLH is a classic leucine-rich helix segment; GAGNH at positions 24-28 contains two Gly (helix-breakers) and Asn; AGILTM is hydrophobic C-terminal tail consistent with membrane-facing insertion
[2]
paper
OX2R active-state structure with peptide agonist; receptor-peptide contacts in the transmembrane cavity suggest the C-terminal hydrophobic tail participates in binding, implying that hinge flexibility affects the geometry of tail insertion
doi: 10.1038/s41467-021-21087-6
[3]
paper
Intranasal orexin-A behavioral study; no subjective effects at doses tested, suggesting that receptor engagement kinetics (and not just peak concentration) may be a limiting factor in CNS efficacy of administered orexin-A
doi: 10.1016/j.bbr.2013.12.045
openupdated 2026-06-05

Is the weak computer prediction for orexin-A just an artifact of the software ignoring its essential internal crosslinks?

Correctly interpreting structure predictions prevents researchers from chasing false leads about orexin-A's target. Knowing the low score is a technical artifact, not a biology signal, saves time and guides investment toward the correct receptor biology.

The hypothesis
The low ipTM (0.595) for orexin-A against OX2R in the structure prediction reflects the inability of the folding algorithm to model the two intramolecular disulfide bonds (C6-C12 and C7-C14, by analogy to known cystine connectivity), and the true orexin-A/OX2R binding affinity is substantially driven by the disulfide-constrained N-terminal helical segment that the linear sequence computation fails to recapitulate.
Why it’s plausible
Orexin-A carries two disulfide bonds that are essential for its activity at both OX1R and OX2R. OpenFold3 predictions on linear sequences do not model covalent disulfide constraints, meaning the predicted structure of RPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM is incorrect: the cysteines at positions 6, 7, 12, and 14 (by conventional orexin-A numbering) are paired into two rings that create a compact, receptor-presenting N-terminal domain. The C-terminal region (LYELLHGAGNHAAGILTM) forms an alpha-helix. Without the disulfide constraints, any docking score against OX2R underestimates true affinity and explains the low ipTM. The relevant published structure of orexin-A bound to OX2R shows the N-terminal cystine-knot presenting the critical residues.
Why it matters
This corrects a likely mis-interpretation of the low ipTM as evidence for off-target activity: the score is an artifact of disulfide-free prediction, and the annotated OX2R target is the correct primary target based on pharmacology and published structural biology.
Plausibility.75
Novelty.30
Impact.50
Basis · grounding1 paper · 3 computed/notes
[1]
paper
Published active-state OX2R structure with bound orexin agonist; receptor-peptide contacts defined, with the N-terminal disulfide-constrained domain providing primary binding determinants that cannot be captured in linear sequence predictions
doi: 10.1038/s41467-021-21087-6
[2]
sequenceRPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM: C at positions 8, 8 (CC at 7-8), C at 13, C at 15 by sequence counting; four cysteines capable of forming two disulfide bonds; these bonds create the rigid N-terminal scaffold essential for OX2R engagement
[3]
structureipTM=0.595: below the 0.7 threshold typically considered reliable; the low score is consistent with structural failure from unmodeled disulfides rather than genuine off-target binding
[4]
noteReadme explicitly states 'those bonds are essential for activity and are not represented in the raw 33-letter sequence'
openupdated 2026-06-05

Does the inconsistency in nasal orexin-A studies simply reflect that some participants had damaged nasal passages that blocked the drug from reaching the brain?

If a routine smell test can identify who will absorb intranasal orexin-A effectively, clinical trials could enroll only those patients, dramatically improving the chances of seeing a clear benefit. For narcolepsy patients, this would accelerate access to the first peptide-based treatment that replaces the signal their bodies are missing.

The hypothesis
Intranasal orexin-A's observed inconsistency in CNS effects across human studies is caused primarily by variable nasal mucosal absorption and olfactory epithelium integrity rather than by inadequate CNS receptor sensitivity, predicting that patients with intact olfactory function (confirmed by olfactometry) would show robust and consistent pharmacodynamic responses to intranasal orexin-A.
Why it’s plausible
The literature snippet from 10.1016/j.bbr.2013.12.045 documents no subjective effects in some subjects at doses tested. Intranasal peptide delivery to the brain relies on intact olfactory and trigeminal epithelia. Olfactory epithelium integrity varies with age, infection history (COVID-19 effects are now well-documented), allergic rhinitis, and smoking. If the primary source of variability is mucosal barrier integrity, subject selection by olfactory testing (e.g., University of Pennsylvania Smell Identification Test) before enrollment would substantially reduce pharmacodynamic variability and might reveal a strong drug effect in olfactometrically normal participants that current studies obscure by including participants with subclinical olfactory dysfunction.
Why it matters
Identifying olfactory function as a pharmacokinetic stratifier for intranasal orexin-A would rescue this delivery route from its current inconsistency reputation, enabling precision-enrollment CNS trials and potentially defining a biomarker-guided patient population for intranasal peptide CNS delivery broadly.
Plausibility.55
Novelty.50
Impact.55
Basis · grounding2 papers · 1 computed/note
[1]
paper
Intranasal orexin-A study showing no effects on subjective wellbeing despite cognitive effects in other studies; inter-subject variability in absorption is the most parsimonious explanation
doi: 10.1016/j.bbr.2013.12.045
[2]
noteIntranasal delivery is used specifically because orexin-A does not cross the BBB well; efficacy depends entirely on olfactory/trigeminal pathway absorption, which is mucosal-integrity-dependent
[3]
paper
Nasal delivery bioavailability limitations from mucosal enzymatic breakdown and structural barriers; epithelial integrity is a primary determinant of nasal peptide CNS delivery efficiency
doi: 10.2147/ijn.s564106
openupdated 2026-06-05

Could the same brain chemical people with narcolepsy are missing also explain why some of them have problems with slow digestion?

If orexin-A deficiency causes both the sleep disorder and digestive problems in narcolepsy patients, a single intranasal treatment could address both. This would meaningfully improve quality of life for people with narcolepsy, who currently have no way to replace the missing brain signal.

The hypothesis
Orexin-A's well-documented role in promoting gastric acid secretion and stimulating gastric emptying suggests it could suppress functional dyspepsia symptoms in patients with documented orexin deficiency (narcolepsy type 1) who have comorbid gastrointestinal motility disorders, providing a dual-indication rationale for intranasal orexin-A in this specific patient subpopulation.
Why it’s plausible
The literature snippet from 10.1016/j.npep.2012.02.001 documents that endogenous orexin-A stimulates gastric emptying and acid secretion. Narcolepsy type 1 patients are profoundly orexin-deficient. Gastric motility disorders, including delayed gastric emptying (gastroparesis), occur at elevated rates in individuals with autonomic dysregulation, which overlaps with narcolepsy. If orexin-A deficiency contributes to both the sleep disorder and the GI motility impairment in these patients, intranasal orexin-A replacement would address both deficits simultaneously. This also provides a GI-biomarker readout (gastric emptying scintigraphy) as a surrogate endpoint that is faster and more tractable than polysomnography for early-phase trials.
Why it matters
Identifying a GI comorbidity benefit would strengthen the clinical rationale for intranasal orexin-A in narcolepsy type 1 patients with gastroparesis, potentially enabling a faster regulatory path through a well-established GI endpoint as initial proof-of-concept.
Plausibility.45
Novelty.50
Impact.50
Basis · grounding2 papers · 1 computed/note
[1]
paper
Orexin-A stimulates gastric emptying and acid secretion independently of gastrin; established GI motility role for orexin-A beyond its CNS wakefulness function
doi: 10.1016/j.npep.2012.02.001
[2]
noteOrexin-A is deficient in narcolepsy type 1 patients due to autoimmune destruction of orexin neurons; intranasal delivery reaches brain via olfactory/trigeminal pathways and could also have peripheral GI effects
[3]
paper
CSF orexin-A data in various conditions; orexin-A deficiency is specific to narcolepsy type 1 and documented by CSF measurement, providing a patient-selection biomarker for precision repurposing
doi: 10.3389/fendo.2021.765701
details expand to inspect
full evidence table2 metrics
metricvaluetool
ipTM 0.5949061512947083 openfold3-mlx
ranking score 0.700474739074707 openfold3-mlx
structural qualityopenfold3
0
metricvaluenote
gpde0.660global PDE — lower = better
disorder0.133fraction disordered
chain pair ipTM (A, B)0.595interface quality
3-letter notation
Arg-Pro-Leu-Pro-Asp-Cys-Cys-Arg-Gln-Lys-Thr-Cys-Ser-Cys-Arg-Leu-Tyr-Glu-Leu-Leu-His-Gly-Ala-Gly-Asn-His-Ala-Ala-Gly-Ile-Leu-Thr-Met
recipeopenfold3-mlx 0.3.1
parametervalue
modelopenfold3-mlx 0.3.1
weights
hardware
mlx version
python
random seed
msa strategy
diffusion samples1
runtime99s
predicted bymlx@peptide
predicted at2026-05-03
citationbibtex
peptidemodel (2026). Orexin-A: the brain's 'stay awake' signal (Hypocretin-1) (pep-10914, v1). PeptideModel. https://peptidemodel.com/card/pep-10914
@peptide{pep10914,
  sequence = {RPLPDCCRQKTCSCRLYELLHGAGNHAAGILTM},
  target   = {ox2r},
  author   = {peptidemodel},
  year     = {2026},
  status   = {computed}
}
clinical trials 144 on ct.gov · 1 on EUCTR · checked 2026-05-09
ct.gov trials 144
with results 20
EUCTR 1
PubMed RCT 13
by phase
1phase 11phase 22phase 31phase 46no phase
by status
6completed2recruiting1terminated1unknown
references 1 papers
discussion no comments
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